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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 94092

24 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
March 06, 2024
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Exactech, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

24 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 24

Exactech Equinoxe GLENOID,KEELED, CEMENTED, Mates with 38, 41, 44 head, alpha curvature, Sizes: a), Small, Item Number 314-01-02; b) Medium, Item number 314-01-03; c) Large, Item Number 314-01-04, Shoulder Arthroplasty

Z-1402-2024
Recall number
Z-1402-2024
Initiated
March 06, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Exactech, Inc.
Quantity
2077 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH).

Code information

a) Item Number 314-01-02, UDI/DI 10885862084408, Serial Numbers: 0745683, 0747928, 0745666, 0747961, 0747950, 0747985, 0747941, 0747948, 0745671, 0745675, 0747921, 0745670, 0747929, 0747944, 0747995, 0748000, 0745681, 0747932, 0747935, 0747942, 0745684, 0747949, 0747981, 0747991, 0747958, 0802455, 0745677, 0747970, 0802458, 0747977, 0747939, 0745680, 0802390, 0747976, 0745673, 0747952, 0747923, 0747988, 0747980, 0802385, 0802381, 0747982, 0747959, 0747963, 0747930, 0747975, 0745682, 0747938, 0747962, 0802387, 0745674, 0747927, 0802395, 0745669, 0747957, 0747996, 0747974, 0747971, 0747990, 0747993, 0747969, 0802456, 0802457, 0802446, 0802414, 0747992, 0802463, 0802479, 0802410, 0802433, 0802418, 0802437, 0802376, 0745679, 0745665, 0747920, 0802404, 0802428, 0802478, 0748001, 0802400, 0802384, 0747968, 0747973, 0802378, 0802435, 0802477, 0747999, 0747994, 0747933, 0802443, 0802454, 0747964, 0802392, 0802417, 0802460, 0802429, 0802373, 0802452, 0745667, 0802405, 0747925, 0747953, 0802396, 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4127765, 4368683, 4127761, 4368688, 4368694, 4400342, 4400349, 4127762, 4088016, 4088017, 2648781, 3798956, 2980590, 3798961, 4088000, 4088021, 4368696, 4400378, 4127751, 4400345, 4902911, 4902924, 3798966, 3798996, 3798987, 3798984, 2942280, 4400351, 4400374, 4400362, 4400372, 4400361, 4400359, 4088003, 4400367, 4400363, 4127763, 4088028, 4400384, 4400381, 4902921, 4902909, 4902933, 4902915, 4902929, 4400357, 4088029, 4127760, 4088012, 4400387, 4400383, 4902928, 4902923, 4902934, 4902917, 4902914, 4902927, 4940844, 6135162, 6135134, 6135145, 4902932, 4940845, 4902916, 4940849, 6135151, 6135158, 6135138, 6135150, 6135154, 6135146, 6135143, 4400368, 4400346, 4400373, 4902910, 4902919, 4902918, 6135140, 6135141, 6135161, 6135153, 6135160, 6860327, 6860322, 6860324, 6859965, 6859973, 6860325, 6135144, 6135147, 6859957, 6859977, 6860001, 6859976, 6859963, 6860323, 6135164, 6135163, 6135136, 6860335, 6860018, 6859974, 6860017, 6860334; c) Item Number 314-01-04,UDI/DI 10885862084422, Serial Numbers: 0743595, 0743636, 0743647, 0743689, 0743690, 0743682, 0743597, 0743670, 0743659, 0743861, 0743684, 0743617, 0743629, 0743883, 0743900, 0743881, 0743896, 0743917, 0743884, 0743891, 0743901, 0743634, 0743839, 0743844, 0743847, 0743865, 0743648, 0743938, 0743916, 0743649, 1539123, 1497434, 1497436, 1497438, 1497440, 1567324, 1567327, 1567337, 1567335, 1539112, 1567321, 1567331, 1607235, 1750949, 1636287, 1817470, 1636273, 1750964, 1636269, 1750932, 1750937, 1750942, 1806474, 1806479, 1748127, 1817454, 1817456, 1806456, 1806463, 1806464, 1806465, 1806476, 1804567, 1748108, 1806451, 1817464, 1817475, 1806454, 1806460, 1677019, 1677016, 1677025, 1677029, 1677030, 1677038, 1750960, 1748128, 1748136, 1750925, 1817485, 1817486, 1748106, 1748100, 1497437, 1567325, 1636272, 1636274, 1804563, 1909766, 1750935, 2017226, 2017223, 2017217, 1804556, 1909749, 1909780, 1909739, 1909754, 1982465, 1748092, 1750961, 1817471, 1909776, 1748132, 1748130, 1750965, 1982462, 1804558, 1750936, 1677017, 1748137, 1750971, 1817469, 2266856, 2174639, 2266847, 1748087, 2536755, 2550621, 2550641, 2690647, 2690656, 2690653, 2690649, 2690655, 1748083, 1982464, 2690643, 3591837, 2690652, 2690644, 2690638, 3649060, 1909750, 2550627, 2550633, 3591831, 3591838, 3737980, 3737989, 2690650, 2690651, 3737981, 3737984, 3591835, 3591840, 4131605, 4133844, 3954819, 4133856, 4131585, 4131588, 4131595, 4131596, 4131603, 4131600, 4133885, 3954824, 3954787, 3954801, 4133847, 4133859, 4131601, 3954795, 4276343, 4283362, 4283344, 4283359, 4276345, 4475367, 4475369, 4400444, 4475380, 4276340, 4276346, 4861306, 4475371, 4475376, 4475366, 4130254, 4133875, 4283340, 4400438, 4912766, 4947624, 4912764, 4912775, 4912774, 4912765, 4912756, 4861304, 6868091, 6868117, 6868119, 6868123, 6868125, 4947621, 7051986, 6868083, 6868090, 6868094, 6868097, 6868112, 6868113, 6868138, 6868139, 7051994, 7051996, 7051993, 6868093

Distribution pattern

Nationwide and Australia, Austria, Belgium, Brazil, Chile, Canada , China, Colombia, France, Germany, Great Britain, Greece, Guatemala, India, Italy, Japan, Korea, Luxembourg, Malaysia, Netherlands, New Zealand, Portugal, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand

device · product 2 of 24

Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-01-12, b) Medium, Item Number 314-01-13, c) Large, Item Number 314-01-14, Shoulder Arthroplasty

Z-1403-2024
Recall number
Z-1403-2024
Initiated
March 06, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Exactech, Inc.
Quantity
2008 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH).

Code information

a) Item Number 314-01-12, UDI/DI 10885862084439, Serial Numbers: 0744170, 0756603, 0744142, 0744169, 0744178, 0744141, 0744152, 0744182, 0756566, 0756592, 0756611, 0744134, 0744135, 0756591, 0744177, 0756567, 0756582, 0756606, 0756596, 0744179, 0744159, 0744145, 1117515, 1117547, 1117537, 1117517, 1117520, 1117548, 1117510, 1117543, 1117529, 1117502, 1117535, 1117499, 1117508, 1117546, 1117503, 1117528, 1117536, 1117506, 1117545, 1117521, 1117505, 1117512, 1117516, 1272400, 1361060, 1361065, 1272398, 1272401, 1272392, 1272403, 1272408, 0756602, 1117540, 1392234, 1350740, 1350736, 1361070, 1361071, 1392236, 1416355, 1428159, 1428162, 1428163, 1574777, 1574781, 1574788, 1574792, 1574778, 1574794, 1350744, 1574793, 1574780, 1574784, 1361073, 0744144, 1117523, 1117518, 1416362, 1574797, 1428168, 1428172, 1416358, 1392244, 1574795, 1428158, 1272409, 1272396, 1574799, 1574779, 1793114, 1633774, 1734408, 1703819, 1793343, 1793353, 1793350, 1635466, 1703814, 1734399, 1734402, 1793101, 1793095, 1793096, 1793344, 1793348, 1793367, 1793055, 1793355, 1793375, 1793369, 1793374, 1734422, 1633771, 1635464, 1633769, 1633775, 1633779, 1794653, 1793105, 1633777, 1392247, 1350735, 1416357, 1361066, 1361074, 1703820, 1633776, 1793341, 1793067, 1917888, 1917899, 1793100, 1917856, 1917895, 1734417, 1984866, 1703810, 1794659, 1793363, 1734413, 2174254, 1117526, 1384121, 1272405, 1416356, 1793365, 1793357, 1917892, 2017327, 1793043, 1793362, 1793366, 1794663, 1793046, 1794657, 1793098, 1984870, 2174258, 2174251, 2284394, 2284397, 2284392, 2174252, 2393054, 2404334, 2404335, 2404339, 1350731, 1416351, 1793051, 1793104, 1793099, 2536818, 2536808, 2536813, 2679975, 2679986, 2679991, 2679993, 2752696, 2752700, 1793097, 2017338, 1917865, 1793057, 1793059, 1734419, 2017326, 1917872, 2284399, 2469226, 2491265, 2508022, 2508031, 2536783, 2679981, 2752686, 2752684, 2980608, 2980607, 2980602, 2993861, 2980606, 2980609, 2993855, 2993850, 2993858, 3740570, 2679984, 2993867, 2017335, 2536782, 2536781, 2993859, 2993863, 2993869, 2993854, 3740565, 3740562, 3740568, 3740569, 2993865, 2993862, 2980603, 2980604, 2980605, 2993856, 2679977, 3950947, 3950892, 4092056, 2393056, 2752672, 4087712, 4087713, 4304826, 3950950, 4087706, 2752681, 2993857, 2993852, 4468485, 4912816, 4912811, 3740560, 4306258, 4304816, 4306265, 4468494, 4087725, 4087729, 4092059, 3950940, 4884357, 4912814, 4092061, 3950949, 3950963, 4304823, 4306261, 4468489, 4304820, 4304828, 4912806, 4971034, 4884356, 4971036, 4304818, 4468496, 4304808, 4304815, 4087726, 4971033, 4884355, 4884358, 4912808, 4912815, 4306263, 4912819, 6801011, 6800984, 6800988, 6800990, 6800998, 6801008, 6801009, 6801003, 6815714, 6801015, 6800999, 6815709, 6815706, 6801007, 6815703, 6815710, 6815711, 6815715, 6800995, 6800997, 6801017, 6801004, 6801016, 6815698, 6800987; b) Item Number 314-01-13, UDI/DI 10885862084446, Serial Numbers: 0742615, 0742397, 0742650, 0742412, 0742485, 0746496, 0742498, 0742608, 0742432, 0742423, 0742513, 0742616, 0742478, 0742488, 0742489, 0742495, 0742480, 0742494, 0742411, 0742407, 0742398, 0742399, 0742641, 0742516, 0742517, 0768435, 0742393, 0742405, 0742511, 0742637, 0742505, 0742627, 0742438, 0742619, 0742606, 0742609, 0742395, 0742621, 0742618, 0742476, 0742520, 0768458, 0742426, 0742428, 0768443, 0742508, 0742496, 0742429, 0742420, 0742439, 0742612, 0742418, 0768462, 0742493, 0742515, 0742408, 0742640, 0742409, 0742416, 0742396, 0742472, 0768441, 0742430, 0746540, 0742521, 0742503, 0768429, 0746542, 0746531, 0746507, 0742514, 0768440, 0742636, 0742431, 0742622, 0742506, 0768478, 0768430, 0768425, 0742605, 0742436, 0742486, 0742509, 0768448, 0768416, 0742406, 0746519, 0742504, 0746502, 0746522, 0746546, 0742646, 0746491, 0746534, 0746504, 0742647, 0746529, 0742404, 0746524, 0768419, 0746526, 0742624, 0746520, 0746543, 0768479, 0742638, 0746494, 0746518, 0746497, 0746523, 0768413, 0746513, 0746539, 1127270, 0742623, 0742497, 0746541, 0746544, 0746516, 0742649, 0768414, 0746500, 0742630, 0742392, 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1926226, 1831877, 1926221, 1807926, 2043648, 1673731, 1915715, 1757649, 1757610, 1956073, 1834459, 1757623, 1715053, 1757630, 1956067, 2043645, 1956056, 1956082, 1715061, 1915706, 1915710, 1715066, 1926227, 1834447, 1956072, 1956085, 1807915, 1834442, 1926224, 1956061, 1956071, 1956078, 2043649, 2043629, 1757651, 1673709, 2043654, 1834439, 1807927, 1673729, 1807904, 1780293, 1715067, 1831878, 1963715, 1915712, 1757633, 2120786, 2120796, 2120814, 2116508, 2120800, 2120783, 2174521, 2174522, 2120804, 1127251, 1428188, 1552846, 1428192, 1372214, 1757657, 2043614, 1715059, 1715052, 2043652, 1956083, 2043631, 1831875, 1957587, 2043655, 1715065, 1834455, 1915705, 1673716, 1757641, 1780282, 2043636, 1956070, 1956076, 1834457, 2043643, 1956058, 1718023, 1780283, 1715050, 1926229, 2120807, 2116510, 2174520, 2120799, 2120810, 2251358, 2116512, 2251357, 2174519, 2174526, 2120780, 2120790, 2120809, 2174523, 2251371, 2251379, 2120795, 2251375, 2251376, 2299861, 2343436, 2343448, 2343433, 2469241, 2469246, 2469234, 2536838, 2343441, 2299871, 2251374, 2120794, 2299862, 2116517, 2120801, 2120808, 2299875, 2343449, 2299860, 2469250, 2116518, 2116519, 2251360, 1574867, 2043621, 1715064, 1915714, 1915717, 1926225, 1807922, 1834441, 1718018, 1757640, 1757643, 1926223, 1956077, 2043642, 1673733, 2116514, 2116516, 2120803, 2469245, 2505875, 2343438, 2505885, 2505858, 2536840, 2469238, 2536843, 2536846, 2536851, 2536837, 2116509, 2505859, 2505856, 2343431, 2299873, 2343432, 2343435, 2536824, 2251373, 2505860, 2299877, 2299856, 2343440, 2536847, 2536829, 2629660, 2629669, 2648798, 2648807, 2648808, 2648792, 2648795, 2629700, 2629672, 2648801, 2648805, 2648796, 2648797, 2758586, 2758587, 2758589, 2648803, 2629702, 2648799, 2648806, 2648809, 2648793, 2648802, 2648804, 2758583, 2629693, 1831879, 1915711, 1831871, 1715049, 1834438, 2043641, 1718021, 1957589, 1757639, 1956068, 2536825, 2536848, 2469236, 2536839, 2120815, 2343450, 2536844, 2536823, 2536830, 2469259, 2536850, 2960184, 2960188, 2960189, 2978378, 2978374, 2629674, 2629675, 2629677, 2629687, 2629681, 2629664, 2629678, 2629685, 2629698, 2648791, 2978370, 2978380, 2960176, 2960181, 2960182, 2629665, 2978368, 2978376, 2629659, 3587048, 3587053, 3587058, 3587054, 2978379, 3587040, 3587056, 3587078, 3587044, 3587055, 3587069, 2978366, 2978372, 2978373, 2978367, 2960180, 2629699, 2629654, 2758588, 2960173, 2758590, 2758591, 2758584, 2629689, 2629701, 1956066, 2043622, 1956060, 2536842, 2536841, 2120781, 2505879, 2120787, 2251362, 2174517, 2505862, 2251367, 3587065, 2629667, 2853384, 2721361, 3587047, 2960174, 2960178, 3587060, 3587074, 3587051, 3587059, 3587063, 3587072, 3587079, 3587064, 3587073, 3587041, 3587043, 3587066, 3587075, 3587077, 2978377, 2629691, 2960183, 2758593, 2629682, 2978371, 2629670, 3587067, 3915901, 3915906, 3915911, 3963332, 3963334, 3963337, 3963338, 3963347, 3963336, 3963342, 3963351, 3963352, 3915899, 3915900, 3915907, 2299864, 2505882, 2467476, 2299869, 2505866, 2536836, 2343447, 2536831, 3587046, 2853379, 2853395, 2629657, 2721369, 2853391, 2629684, 3587068, 3587042, 2648794, 2629692, 2648790, 2629676, 3963312, 4368744, 4087674, 4368747, 3963329, 4368734, 4400436, 4400433, 4400393, 4400399, 4087687, 3915908, 3963348, 4368732, 3915905, 3963333, 2467477, 2629658, 2629673, 3587070, 2978369, 3587049, 2960172, 2960175, 3587045, 4087678, 4400434, 3963311, 4087693, 4087654, 4400427, 4400416, 3963353, 3963355, 4087680, 4400401, 4368733, 4903234, 4903226, 4903223, 4903231, 3587082, 3963331, 4087677, 4368746, 4400413, 4368735, 4087671, 4087672, 4087668, 4087700, 4400432, 3963315, 4368738, 4400391, 3915898, 4400398, 4087702, 3963308, 3963317, 4087695, 4087657, 4400408, 4087681, 4400429, 3963343, 4931752, 4903238, 4875887, 4903233, 4400424, 4087673, 4400409, 4368741, 4087655, 4087682, 4087660, 3963322, 4400428, 4368730, 4368731, 4931762, 4931755, 4931770, 4931754, 4903239, 4931760, 4931767, 4875873, 4875878, 4875872, 4875886, 4931756, 4931768, 6134622, 6134646, 4087662, 4087670, 4400422, 4875880, 4931769, 4875877, 4875871, 4875875, 6134717, 6134732, 6134715, 6134708, 6134721, 6134726, 6134734, 6134725, 6134674, 6134624, 6134672, 6134654, 4400418, 4368736, 4400423, 4368745, 4875882, 4931757, 4875874, 4875881, 6134712, 6134665, 6134647, 6134639, 6134633, 6134648, 6134650, 6134676, 6134720, 6883308, 6883305, 6883316, 6883303, 7056640, 6883314, 6883295, 6883325, 6883298, 6883299, 6883318, 4875884, 4931761, 6134658, 6134640, 6134636, 6134644, 6134657, 6134662, 6134669, 6883311, 6883328, 6883321, 6134722, 6883307, 6883304, 6883327, 7056652, 7056641; c) Item Number 314-01-14, UDI/DI 10885862084453, Serial Numbers: 0742666, 0742660, 0742675, 0742662, 0742696, 0742663, 0742686, 0743043, 0742659, 0742992, 0742678, 0742682, 0742999, 0743006, 0743041, 0742657, 0742658, 0742661, 0742697, 0742668, 0743005, 0743003, 0743012, 0903127, 0743039, 0742993, 0743018, 0742688, 0742990, 0742672, 0743020, 0743035, 0742680, 0743011, 0743026, 0742991, 0903170, 0903164, 0903150, 0743023, 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Distribution pattern

Nationwide and Australia, Austria, Belgium, Brazil, Chile, Canada , China, Colombia, France, Germany, Great Britain, Greece, Guatemala, India, Italy, Japan, Korea, Luxembourg, Malaysia, Netherlands, New Zealand, Portugal, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand

device · product 3 of 24

Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-02, b) Medium, Item Number 314-02-03, c) Large, Item Number 314-02-04, Shoulder Arthroplasty

Z-1404-2024
Recall number
Z-1404-2024
Initiated
March 06, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Exactech, Inc.
Quantity
6678 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH).

Code information

a) Item Number 314-02-02, UDI/DI 10885862084477, Serial Numbers: 0747871, 0747855, 0747853, 0747858, 0747827, 0747805, 0747814, 0747845, 0747781, 0747779, 0747823, 0747835, 0747804, 0747813, 0747839, 0747775, 0747838, 0747798, 0747846, 0747825, 0747841, 0747832, 0747837, 0747776, 0768035, 0747816, 0747833, 0747872, 0747844, 0747847, 0747803, 0747809, 0747818, 0747860, 0747808, 0747824, 0747859, 0747801, 0747840, 0747829, 0747831, 0747799, 0747794, 0747782, 0768047, 0768042, 0768033, 0768068, 0768058, 0747784, 0747857, 0747778, 0747797, 0747802, 0747810, 0747777, 0747865, 0768012, 0768064, 0768041, 0768086, 0747787, 0747830, 0768031, 0768063, 0768097, 0747828, 0768092, 0768006, 0768004, 0747863, 0767999, 0768076, 0768080, 0747826, 0747850, 0768087, 0747783, 0768010, 0768034, 0768038, 0747870, 0768060, 0768043, 0768089, 0768077, 0747812, 0768093, 0768073, 0768025, 0747852, 0747780, 0747843, 0747791, 0747854, 0747795, 0768065, 0747864, 0768020, 0768101, 0768011, 0747820, 0768051, 0768098, 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6833597, 6847138, 7042223, 7042272, 7041540, 7042261, 7041534, 6833594, 6853827, 7041514, 7042227, 7041516, 7041507, 7042276, 6853831, 7041505, 6833605, 6847125, 6847128, 6833336, 6462907, 6833461, 6462908, 6520974, 6204406, 6204325, 6853840, 6462920; b) Item Number 314-02-03, UDI/DI 10885862084484, Serial Numbers: 0777367, 0745391, 0777366, 0777351, 0774821, 0745373, 0777363, 0745384, 0774826, 0747902, 0774820, 0777359, 0747919, 0745390, 0747912, 0774852, 0774803, 0774818, 0774842, 0774817, 0774840, 0747911, 0774811, 0774806, 0745389, 0774807, 0774832, 0774847, 0774812, 0774838, 0774839, 0774827, 0747914, 0745383, 0774844, 0745386, 0774846, 0924471, 0777355, 0777350, 0774850, 0774814, 0924497, 0774831, 0774801, 0747905, 0774800, 0745380, 0745385, 0745388, 0774809, 0747908, 0777362, 0774841, 0747918, 0747900, 0924480, 0774851, 0774804, 0774815, 0774823, 0774825, 0774843, 0777353, 0747915, 0924473, 0924467, 0745377, 0924484, 0774802, 0924457, 0777361, 0924466, 0924488, 0924481, 0924494, 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Distribution pattern

Nationwide and Australia, Austria, Belgium, Brazil, Chile, Canada , China, Colombia, France, Germany, Great Britain, Greece, Guatemala, India, Italy, Japan, Korea, Luxembourg, Malaysia, Netherlands, New Zealand, Portugal, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand

device · product 4 of 24

Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02-14, d) Extra Large, Item Number 314-02-15, Shoulder Arthroplasty

Z-1405-2024
Recall number
Z-1405-2024
Initiated
March 06, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Exactech, Inc.
Quantity
6840 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH).

Code information

a) Item Number 314-02-12, UDI/DI 10885862084507, Serial Numbers: 0790902, 0790901, 0790903, 0790904, 0790907, 0790908, 0790910, 0790919, 0790899, 0790912, 0797553, 0790917, 0797597, 0797605, 0797554, 0797582, 0790914, 0797567, 0797583, 0790900, 0797537, 0797606, 0790918, 0797559, 1340014, 1356689, 1356703, 1361002, 1361004, 1388246, 0797538, 0797563, 0797603, 0797573, 0797560, 0797572, 0797578, 0790898, 0797550, 0797574, 0790893, 1340017, 1340012, 1425621, 1388234, 1388236, 1425335, 1425344, 1360995, 1535521, 1356704, 1425620, 1340013, 1361005, 1425347, 1425626, 1425636, 1425338, 1425629, 1591628, 1591621, 1425334, 1360998, 1388247, 1425619, 1425634, 0797602, 0797552, 0797540, 0797587, 0790897, 1594675, 1356696, 1535516, 1591609, 1594683, 1591634, 1535523, 1594687, 1361008, 1340015, 1591616, 1425341, 1594692, 1425627, 1594681, 1522746, 1591610, 1425349, 1425351, 1388245, 1594693, 1591627, 1340010, 1704508, 1667046, 1704498, 1704531, 1802791, 1704533, 1802807, 1893661, 1704491, 1704530, 1704506, 1704526, 1864986, 1802815, 1704488, 1783187, 1667062, 1864969, 1864971, 1704500, 1704504, 1667056, 1704484, 1704501, 1704535, 1704494, 1704502, 1704536, 1667036, 1704521, 1704519, 1704524, 1802802, 1704522, 1802816, 1802818, 1704532, 1802795, 1802825, 1802810, 1802801, 1802804, 1704513, 1704517, 1888844, 1704514, 1704485, 1704486, 1704487, 1704493, 1704497, 1783178, 1802812, 1802821, 1864974, 1535512, 1425336, 1356706, 1591613, 1594678, 1425330, 1340011, 1356698, 1356690, 1594696, 1388239, 1425622, 1425329, 2048566, 1909798, 1802823, 1909794, 1802806, 1909801, 1667052, 1955133, 1704509, 1926351, 1667041, 1864990, 1802800, 1704489, 1888845, 2073046, 1783186, 1888841, 1802796, 1955140, 1783180, 1802799, 1704529, 1909797, 1783190, 1667054, 1783189, 1783184, 1909813, 1888849, 1864993, 1667057, 1909808, 2073051, 1888843, 1893653, 2073035, 2073043, 1909803, 2048551, 2048535, 1667033, 2048568, 2118375, 2118380, 2118381, 2118387, 1425631, 1361000, 1591626, 1591614, 1425331, 1535524, 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4836949, 5154874, 4810718, 5154872, 5247531, 4810721, 5247525, 5237122, 5237124, 5154882, 5060134, 5154863, 5015187, 5015176, 4836960, 5154881, 4776103, 5075647, 5154878, 5237098, 4903154, 4903159, 5154877, 4776097, 4903149, 4875856, 4921377, 5237108, 5015163, 4875857, 5060140, 4875842, 4875855, 5154871, 5247532, 5247548, 5247530, 4875854, 5075642, 5060138, 5060143, 4875859, 4810706, 5015193, 4921384, 3617027, 3583198, 3601480, 3641050, 4474060, 3898815, 4474065, 4444455, 3898839, 4444459, 4384650, 4474078, 3959666, 4267066, 4474076, 3915951, 3927965, 4384665, 3927961, 4836965, 5015149, 5237121, 5060148, 5015152, 48

Distribution pattern

Nationwide and Australia, Austria, Belgium, Brazil, Chile, Canada , China, Colombia, France, Germany, Great Britain, Greece, Guatemala, India, Italy, Japan, Korea, Luxembourg, Malaysia, Netherlands, New Zealand, Portugal, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand

device · product 5 of 24

Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, LEFT, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-02-22, b) 41, 44, 47, 50 head, Medium, Item Number 314-02-23, c) 44, 47, 50, 53 head, Large, Item Number 314-02-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-02-25; Shoulder Arthroplasty

Z-1406-2024
Recall number
Z-1406-2024
Initiated
March 06, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Exactech, Inc.
Quantity
805 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH).

Code information

a) Item Number 314-02-22, UDI/DI 10885862175052, Serial Numbers: 1984576, 1984575, 2090821, 1984570, 1984581, 1984569, 2090824, 2093611, 2090832, 2090825, 2379003, 2090861, 2090820, 1984577, 2090843, 2378999, 2379029, 2425682, 2378998, 2090854, 2425684, 2093636, 2090855, 2093634, 2425676, 1984573, 2485867, 2379017, 2090842, 2640254, 2640262, 2640255, 2754817, 2093618, 2379019, 2090826, 2640241, 2654891, 2093613, 2093621, 2654890, 2485860, 2425689, 2090863, 2425683, 2654887, 2628323, 2640277, 2951278, 2961486, 2090862, 2090850, 2640252, 2640279, 2654888, 2654892, 2654894, 2379025, 2640261, 2754818, 3600551, 3600548, 3600552, 3600562, 3600553, 3600561, 3600565, 3600560, 3600550, 3600559, 2090852, 2654893, 2425667, 2145999, 2425669, 2594873, 2640268, 2628315, 2640280, 2754815, 2983602, 4523829, 4523835, 3936374, 3570106, 3570101, 3570098, 3936367, 2640271, 3941936, 3600547, 4431925, 4987572, 4987573, 4925598, 2640257, 4497767, 3600546, 3936376, 3600556, 4459029, 3570097, 4459036, 5304678, 5404184, 5304679, 5320000, 5061891, 4651003, 4780605, 4475610, 4485961, 4485962, 5159660, 5540792, 5540797, 5320009, 5404188, 4666781, 5304682, 5319984, 5883347, 5883348, 5929682, 5929698, 5929699, 5883346, 5883355, 5883354, 5883340, 5883335, 5540799, 5404170, 5304686, 5304681, 5883344, 5929692, 4459042, 5320016, 4780611, 5540804, 5404178, 5929691, 6847326, 6847328, 6847320, 6847321, 6847332, 5929703, 5929684, 5159648, 5404185, 5304675, 5304710, 5404171, 4917534, 6847341, 6847323, 6847336, 5929687, 5883339, 7034749, 7034750, 7034755, 7034756, 7034759, 7034751, 6847334, 6190062, 6847333; b) Item Number 314-02-23, UDI/DI 10885862175069, Serial Numbers: 1984153, 1984161, 2093802, 2093792, 2067826, 1984166, 2067811, 1984159, 2067793, 2067816, 2150615, 2067802, 2093779, 2426046, 2150607, 2150602, 1984163, 2067809, 2093772, 2067813, 1984168, 2426089, 2093783, 2067822, 2067803, 2426036, 1984167, 2093788, 2067835, 1984154, 1984160, 2150631, 2067815, 2067789, 2093764, 2093773, 2093805, 2426084, 2093780, 2093799, 2426065, 2479772, 2559240, 2067831, 2479781, 2093778, 2426047, 2426082, 2426061, 2426057, 2479771, 2150627, 2067797, 2093765, 2479764, 1984169, 2426088, 2559239, 2093789, 2093793, 2093768, 2093810, 2479776, 2426041, 2591548, 2628326, 2426045, 2640307, 2640293, 2747836, 2747853, 2067790, 2559246, 2426060, 1984165, 2150617, 2067808, 2150638, 2067791, 2067796, 2067810, 2150616, 2067786, 2426049, 2067829, 1984156, 2559243, 2559247, 2559250, 2640315, 2067800, 2559252, 2067801, 2426058, 2093785, 2479779, 2479768, 2426076, 2426080, 2067818, 2628329, 2426063, 2628327, 2747842, 2942478, 2747843, 3570244, 2942482, 3570242, 2942481, 3570226, 2976331, 2747850, 3570245, 2976334, 3570234, 2747851, 3570223, 2976335, 2067833, 2150620, 2479780, 2426087, 2093776, 2067806, 2640290, 2426052, 2426053, 2150628, 2150640, 2426079, 2150600, 2067792, 2479766, 2093794, 2067834, 2093774, 2093800, 2093813, 2640311, 2559245, 2093786, 2067812, 2640312, 2640319, 2628330, 2640294, 2747854, 3759705, 2976336, 3896104, 2942496, 2747839, 3759697, 3759692, 2942494, 2942483, 3759698, 3759689, 3759694, 3759696, 3759703, 3759706, 3759707, 3825275, 3825282, 3600585, 3600580, 3600581, 2150635, 2479774, 2150603, 2479765, 2640302, 2067823, 2640308, 2150629, 2628325, 2942490, 3825272, 2747841, 3896091, 2942492, 3896120, 3570225, 2942476, 3570229, 4512379, 3896122, 3600577, 3896114, 3600568, 4398412, 4512381, 3600571, 3570235, 2628328, 4398425, 4475599, 4512377, 2942493, 3896124, 3825280, 3570240, 4520235, 3600567, 3600572, 3600575, 3570228, 4398429, 3600569, 3896116, 3896121, 3825274, 3896111, 4780792, 4780793, 3825283, 3570239, 3925787, 3825284, 3896113, 3759693, 3925783, 5076184, 5139193, 5351490, 4780789, 4587489, 5076182, 5291504, 5599689, 5599680, 5599693, 5599697, 3570231, 4523839, 3896103, 5291510, 5159878, 5291501, 4587485, 5866689, 5866684, 5599683, 5866680, 5866688, 5866690, 5866685, 5599687, 5599681, 5578263, 5599672, 5929665, 5599688, 3896112, 4398421, 4780784, 4780787, 4780786, 6135397, 5929672, 6135422, 5929653, 6135403, 6135399, 5929667, 4523840, 5351476, 5428701, 5428675, 5139195, 5076181, 5291522, 5291499, 5929674, 6576862, 6839511, 5929651, 6839502, 6576860, 6839534, 6839536, 6135418, 6576847, 6576857, 6839500, 5599692, 6849234, 5428689, 5291506, 5291520, 5291498, 5428674, 5351478, 5351482, 5578267, 6839538, 6839501, 5929660, 5747339, 5599669, 6576850, 6576866, 5929654, 6839516, 5929659, 5866682, 6135413, 6576855, 5929652, 6135416, 5599679, 6839539, 5599691, 6576852, 6849248, 6135410, 5599668, 6849235, 5747356, 5599700; c) Item Number 314-02-24, UDI/DI 10885862175076, Serial Numbers: 1984246, 2073722, 1984239, 1984245, 2073700, 1984236, 2073696, 2073694, 1984241, 1984248, 2094924, 2073690, 2094918, 2094908, 2485852, 2094929, 2094903, 2146925, 2073728, 2073692, 1984242, 1984250, 2073727, 1984243, 2094935, 2094891, 2094920, 2094910, 2427421, 2073684, 2146930, 2413530, 2413532, 2413541, 2413516, 2413539, 2485857, 2413544, 2485854, 2073683, 2146929, 2427413, 2637799, 2413517, 2621366, 2637785, 2073707, 2094893, 2485843, 2485845, 2637776, 1984249, 2073724, 2073686, 2637805, 1984244, 2427412, 2413509, 2073719, 2413520, 2485842, 2073714, 2094897, 2073688, 2413518, 2637807, 2485851, 2094923, 2637771, 2146918, 2413553, 2427415, 2413491, 2413502, 2594881, 2752416, 2637782, 2146917, 2637763, 2637778, 2094904, 2094926, 2146932, 2427417, 2413555, 2094911, 2413536, 2637768, 2637777, 2073731, 2094934, 2413494, 2146921, 2427414, 2413558, 2094892, 2073713, 2073725, 2637797, 2073687, 2752403, 2877181, 2752412, 2942509, 2942514, 2752417, 2942512, 2877182, 2752407, 2752408, 2413551, 2073699, 2094922, 2073721, 2073704, 2413514, 2621367, 2413501, 2637803, 2637787, 2637796, 2094927, 2413508, 2413490, 2637775, 2413499, 2073709, 2073732, 1984240, 2583785, 2942516, 2877177, 3574668, 2961490, 2752411, 3574654, 3825267, 2877179, 2961494, 3574644, 2942497, 3574641, 3951688, 3574645, 3574647, 3574652, 3574659, 3574661, 3574669, 3574653, 3574658, 3574649, 2621365, 2073691, 2413545, 2146920, 2413548, 2485855, 2637794, 3574665, 3574646, 2961487, 3951686, 4122915, 3825264, 4475631, 4523817, 4122898, 2961489, 4122892, 4122919, 2413533, 2637774, 2637773, 2594879, 2621369, 2637795, 3825258, 4454025, 2752414, 3936360, 4454020, 4122906, 4122893, 3825262, 2637801, 3825270, 4122918, 4475633, 3574670, 5318756, 4587407, 5103433, 5561023, 5561025, 5561002, 3825261, 4122902, 3936362, 3936359, 3936364, 4122907, 4790524, 5316541, 5538731, 5318765, 5929367, 5717019, 5833709, 6222491, 6222495, 6218718, 6218730, 6218733, 6218731, 5833719, 5561024, 4523819, 5318759, 5929361, 6222500, 6222509, 6222502, 5717012, 4790527, 5061884, 4951247, 5316550, 5538723, 5318764, 5103432, 4684863, 5318760, 4790525, 5538729, 6218719, 6847302, 5833716, 6222507, 6223922, 5561003, 6824907, 6847306, 5929353, 5561013, 5179799, 5061879, 5316535, 5717020, 6222496, 5561018, 6222506, 6824899, 6824888, 6824894, 5561008, 5929360, 5561004, 5929345, 6222499, 6847289, 6218740, 5929350, 6222487, 6218724, 6222486, 5929354, 5717011, 6218720, 5929358, 5717024; d) Item Number 314-02-25, UDI/DI 10885862175083, Serial Numbers: 1984594, 1984595, 1984596, 1984593, 2086796, 2147635, 2485875, 2637753, 2167696, 2147618, 2147649, 2419041, 2147644, 2142520, 3592854, 3571536, 2591549, 4555103, 4521883, 4925728, 4148695, 4607449, 5163430, 4572652, 4521882, 5543395, 4607452, 5319922, 5543410, 5543408, 5319946, 5960413, 5381658, 5960424, 4607451, 6872159, 4925733, 5319919, 5319942, 5381668, 5163412, 5960410

Distribution pattern

Nationwide and Australia, Austria, Belgium, Brazil, Chile, Canada , China, Colombia, France, Germany, Great Britain, Greece, Guatemala, India, Italy, Japan, Korea, Luxembourg, Malaysia, Netherlands, New Zealand, Portugal, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand

device · product 6 of 24

Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, RIGHT, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-02-32, b) 41, 44, 47, 50 head, Medium, Item Number 314-02-33, c) 44, 47, 50, 53 head, Large, Item Number 314-02-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-02-35; Shoulder Arthroplasty

Z-1407-2024
Recall number
Z-1407-2024
Initiated
March 06, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Exactech, Inc.
Quantity
985 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH).

Code information

a) Item Number 314-02-32, UDI/DI 10885862175052, Serial Numbers: 2090670, 1984370, 2086996, 2090655, 2108671, 2086997, 2086999, 2379424, 2479807, 2640374, 2142682, 2147846, 2142679, 2479798, 2090659, 2147857, 2147847, 2640379, 2090665, 2086983, 2640371, 2142675, 2147834, 2086981, 2640406, 2086998, 1984369, 2147853, 2640397, 1984379, 2628334, 2640377, 2640375, 2640384, 2752430, 3570463, 3570474, 2640372, 2142674, 1984378, 2379426, 2640380, 2640391, 2640394, 2640395, 2640403, 2640410, 2379418, 2594876, 2640385, 3616755, 3616759, 3758373, 3616754, 3570473, 2983574, 3570462, 3570461, 3570454, 1984381, 2086989, 2147814, 2086988, 2147828, 2640408, 2594877, 2958057, 3970792, 2788748, 3970793, 2752423, 3970794, 4469187, 3616757, 4587423, 2379417, 2594878, 2788750, 2752418, 3570460, 4469183, 2958061, 3570459, 4591595, 4657525, 4657526, 4807291, 4657530, 2752421, 4469189, 4209410, 3570469, 3616758, 4602056, 5349352, 4591598, 5161352, 4485953, 4141933, 4409893, 4469185, 4520246, 5540785, 5540764, 5279160, 5540774, 5540781, 5540777, 5540773, 5929633, 5929646, 4497764, 4807288, 5519031, 5161362, 5161370, 5929643, 5929635, 5929624, 4409904, 5349329, 5349336, 5349327, 6846318, 6130751, 6130754, 6130763, 6846297, 6846301, 6846314, 6823520, 4651619, 6823534, 5929622, 7008973, 7008965, 5540789, 5929640; b) Item Number 314-02-33, UDI/DI 10885862175069, Serial Numbers: 2084927, 1985029, 2084773, 2141202, 1985036, 1985027, 2084781, 2084788, 2084783, 1985020, 2084904, 2084930, 1985024, 1985031, 2084771, 2084763, 2379448, 2084766, 2084920, 2084774, 2084772, 2426118, 2084779, 2084916, 1985028, 2141200, 2084914, 2149805, 1985033, 2485893, 2084919, 2149803, 2149820, 2105746, 1985030, 1985021, 2084764, 2149823, 2149828, 2149800, 1985032, 1985026, 2105745, 2149810, 2379454, 2379466, 2426097, 2149824, 2485884, 2426446, 2084922, 2379465, 2149811, 2426423, 2426447, 2084777, 2149788, 2149809, 2426427, 2379453, 2084769, 2149832, 2426117, 2426434, 2426418, 2141204, 2426114, 2149787, 2426101, 2149831, 2084924, 2426091, 2426413, 1985023, 2426439, 2084768, 2084765, 2149801, 2485898, 2426417, 2426125, 2084931, 2426422, 2379467, 2084923, 2628343, 2426112, 2628341, 2752437, 2684242, 2684245, 2700673, 2700682, 2752438, 2684223, 2684218, 2426113, 2426105, 2426102, 2084917, 2426437, 2084770, 2084780, 2426438, 2084776, 2149816, 2149808, 2485891, 2426426, 2485890, 2485897, 2141203, 2426444, 2379451, 2485889, 2149794, 2149785, 2485894, 2084787, 2426109, 1985035, 2426428, 2149819, 2149818, 2084928, 2149815, 2426103, 2149830, 2426432, 2628344, 2628342, 2684233, 2684220, 3637081, 2752446, 2942529, 2983586, 2942544, 2752449, 2942532, 2942521, 2983591, 2684227, 2873830, 2700679, 2752442, 2942531, 2684235, 2752447, 2983590, 2752445, 2983592, 2752439, 2983598, 2684238, 3574187, 3574162, 2752431, 2752436, 2684219, 3574185, 2942536, 3574166, 3574160, 3574182, 2684217, 3574181, 2149822, 2084905, 2426120, 2149791, 2084778, 2426092, 2149817, 2426104, 2149806, 2105744, 2426424, 2426443, 2149829, 2426106, 2426441, 2141201, 2149821, 2426111, 2485882, 2426425, 2485892, 2149789, 2752440, 3925823, 2873828, 3574186, 2942542, 3637092, 2700675, 3574188, 2942545, 3896139, 2942522, 3574174, 2684229, 3812899, 2942519, 3837391, 3837393, 2942538, 3637077, 3574175, 3837384, 3574163, 2684216, 2684222, 2700672, 3837400, 3637089, 3896134, 3574173, 3637069, 3637070, 3637071, 3637072, 3637079, 3637085, 3837396, 3842912, 3842911, 2873836, 3574189, 3574170, 3574184, 3574180, 3574183, 2684239, 3637078, 2084913, 2149825, 2591552, 2426436, 2426093, 2379457, 2873825, 3574167, 4113904, 4113894, 2983595, 2684224, 3925832, 3925826, 3574171, 2700671, 3637093, 4113892, 4113901, 4551913, 4398954, 4113900, 4113890, 3842914, 3896138, 3896131, 4398959, 3842913, 3637083, 4113897, 3637067, 2873832, 3637073, 3896137, 4398961, 3637095, 2426096, 3837394, 2684228, 3925820, 3896140, 3896136, 4113881, 4398967, 4512761, 4398962, 4398963, 4113905, 4685394, 3637094, 3925825, 4113898, 3837397, 4113907, 3925833, 3574165, 4398970, 4512756, 4398955, 3925816, 4551917, 4512755, 5387840, 5519105, 5349433, 5279877, 5279797, 5387821, 4780811, 4825319, 5279863, 4113906, 3896142, 4512762, 5519103, 5387826, 4685397, 5387829, 5387824, 5875156, 5743581, 5875144, 5743582, 5875163, 5929442, 5929443, 5929449, 6129392, 6129407, 5743594, 5929452, 5875162, 6129395, 5875168, 5929468, 5929446, 4113885, 4398965, 4780809, 5349421, 4825327, 4825326, 6129402, 6129410, 5929467, 6129394, 5743593, 6389101, 5875169, 5743579, 4825318, 5349411, 5279784, 4825324, 4780817, 4825323, 5279788, 5349422, 5387822, 6389081, 6129401, 6832085, 6584616, 5743589, 6129398, 6389102, 6389096, 6584617, 6584623, 5743590, 5929445, 6129405, 5929469, 6584622, 5387837, 5279862, 5279798, 5279867, 5929459, 5743725, 6584619, 5743732, 6129409, 6389080, 6832069, 5929461, 5875157, 5929457, 5743591, 6129393, 5743592, 6832075, 5929441, 5875161, 5875146, 5929447, 6832083, 5743734, 5743585, 6832079, 6832082, 6129408, 6584631, 5743595, 6584630, 6584615; c) Item Number 314-02-34, UDI/DI 10885862175076, Serial Numbers: 1984798, 1984806, 1984812, 1984803, 2093504, 2150262, 2150261, 1984799, 1984801, 2083436, 2093481, 1984797, 1984800, 1984802, 2083426, 2083430, 2150268, 2093474, 2293111, 2293101, 2425166, 1984805, 2083450, 2083469, 2425157, 2083464, 2083432, 2093515, 2093483, 2093516, 2425180, 2150270, 2093513, 2083459, 2293104, 2150265, 2083441, 2083445, 2093505, 2093472, 2083455, 2083460, 1984809, 2482931, 2425152, 2083446, 1984810, 2093491, 2083437, 2083443, 2083440, 2293109, 2150271, 2150264, 2093497, 2093487, 2093482, 2093506, 2425162, 2425170, 2425155, 2425153, 2093521, 2093473, 2083470, 2093502, 2640438, 2093511, 2083434, 2640449, 2425169, 2425134, 2083429, 2150274, 2083427, 2293124, 2293114, 2425161, 2425138, 2093503, 2628346, 2425159, 1984808, 2482933, 2425168, 2150278, 2083442, 2093475, 2293125, 2083457, 2083471, 2640443, 2083425, 2425148, 2482937, 2482926, 2425135, 2293100, 2293105, 2482936, 2093496, 2425173, 2293106, 2150272, 2083454, 2747880, 2747861, 2425124, 2425121, 2425147, 2425128, 2425129, 2425115, 2293122, 2425127, 2083433, 2083466, 2083444, 2640427, 2640435, 2083424, 2150277, 2640426, 2093489, 2425122, 2425123, 2093514, 2425144, 2425176, 2083462, 2482927, 2482928, 2293120, 2083452, 2425154, 2293121, 2640419, 2425132, 2093476, 2093488, 2640421, 2640429, 2425126, 2640450, 2093507, 2425172, 2425185, 2640428, 2425165, 2293098, 2482929, 2640414, 3570485, 3570493, 2877202, 2877206, 2747863, 2983582, 2983584, 2747865, 3570480, 2877207, 2754566, 2747868, 3570501, 2877210, 3570487, 2877211, 3741125, 2877215, 2967532, 3570483, 3570494, 2958315, 2747869, 2754561, 2754557, 3570490, 2747872, 3570489, 2628349, 2482930, 2640447, 2425149, 2293115, 2093495, 2093484, 2083422, 2640430, 2425146, 2083439, 2093478, 2640417, 2640432, 2083456, 2640440, 1984811, 2482925, 2083458, 2293127, 2293112, 2150279, 3570484, 3826845, 3741116, 3741115, 2747871, 2958320, 2877200, 3896159, 3896169, 3795618, 3570481, 3826852, 2983581, 3685423, 2958319, 3685428, 3896166, 3570496, 2754562, 3741117, 3896151, 3685421, 3685424, 3741123, 3741124, 3795624, 3795626, 3826860, 3896163, 2747878, 2967531, 3570492, 3896177, 3685422, 2425117, 2093509, 2425137, 1984813, 2640420, 2482932, 2586933, 2640441, 2640415, 3570477, 2877198, 3826862, 3826855, 4083724, 3826854, 2754560, 2967525, 2877199, 3896165, 2747873, 4083718, 4083723, 3997148, 4083719, 3896176, 3896154, 3570482, 2640439, 2425151, 2640437, 3896153, 4470778, 4512752, 3741127, 2877212, 2958316, 2747879, 3685426, 3896178, 2877208, 4083721, 4095017, 4470772, 5076175, 5076176, 5139720, 2747874, 4470774, 4095014, 4095018, 4083717, 3896172, 3685429, 3570479, 4470779, 5168349, 5496225, 5168337, 5496219, 5168339, 5655294, 5655304, 2628347, 3795623, 3896180, 4398972, 5168338, 4765131, 5168343, 5565653, 5691680, 5655307, 5691671, 5691672, 5691660, 5967231, 5967253, 5691673, 6218710, 5655301, 5967241, 6218690, 5565656, 4095015, 5496227, 5496235, 5351507, 6389254, 6389247, 6389243, 6218704, 5565647, 5967244, 4512749, 4475619, 4790541, 4790542, 5496231, 5351518, 5280312, 4790535, 5496237, 5967230, 6218716, 5655299, 6389230, 6218706, 5691678, 5565646, 6218702, 6218713, 6623276, 6623281, 6623293, 5691666, 5691674, 5655303, 5655290, 5691663, 5691684, 5967240, 5967251, 5967229, 4475628, 5351495, 5280322, 5168340, 5351516, 5496211, 5565649, 5655302, 6218698, 5655298, 5655293, 6623289, 6905374, 6905376, 6905377, 6905380, 6905408, 5691675, 6218714, 6905412, 6905396; d) Item Number 314-02-35, UDI/DI 10885862175083, Serial Numbers: 2084874, 1985093, 1985091, 2084879, 1985097, 1985106, 1985104, 2084859, 1985102, 1985094, 2169727, 1985095, 2138724, 2138702, 2640472, 2169725, 2084895, 2084896, 2378032, 2378023, 2378019, 2169726, 2378021, 2084882, 2084857, 3571551, 2961483, 2752463, 1985096, 2640480, 2378026, 2138699, 2640495, 2378030, 2479841, 1985100, 2752457, 4523804, 4442573, 5359162, 4442577, 4442570, 5280146, 5457321, 5457335, 5957970, 5957988, 5957990, 5875196, 5875186, 5359158, 5133528, 4442575, 4466032, 5457333, 5359153, 6713270, 4523806, 5143289, 5359164, 6986597, 6986605, 6986609, 6986611, 6986614, 5511964

Distribution pattern

Nationwide and Australia, Austria, Belgium, Brazil, Chile, Canada , China, Colombia, France, Germany, Great Britain, Greece, Guatemala, India, Italy, Japan, Korea, Luxembourg, Malaysia, Netherlands, New Zealand, Portugal, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand

device · product 7 of 24

Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 12o, LEFT, FOR CEMENTED USE ONLY, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-04-22, b) 41, 44, 47, 50 head, Medium, Item Number 314-04-23, c) 44, 47, 50, 53 head, Large, Item Number 314-04-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-04-25; Shoulder Arthroplasty

Z-1408-2024
Recall number
Z-1408-2024
Initiated
March 06, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Exactech, Inc.
Quantity
35 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH).

Code information

a) Item Number 314-04-22, UDI/DI 10885862199553, Serial Numbers: 2111946, 2136867, 2136870, 2427405; b) Item Number 314-04-23, UDI/DI 10885862199560, Serial Numbers: 2111953, 2111954, 2139294, 2111955, 2139292, 2139291, 2139288, 2139290, 2424307, 2424304, 2111952, 2424306, 2424314, 2424305, 2482942; c) Item Number 314-04-24, UDI/DI 10885862199577, Serial Numbers: 2111949, 2111950, 2153613, 2153608, 2153607, 2153611, 2153612, 2421997, 2153609, 2421992, 2111951, 2153610, 2421994; d) Item Number 314-04-25, UDI/DI 10885862199584, Serial Numbers: 2112018, 2112019, 2427567

Distribution pattern

Nationwide and Australia, Austria, Belgium, Brazil, Chile, Canada , China, Colombia, France, Germany, Great Britain, Greece, Guatemala, India, Italy, Japan, Korea, Luxembourg, Malaysia, Netherlands, New Zealand, Portugal, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand

device · product 8 of 24

Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 12o, RIGHT, FOR CEMENTED USE ONLY, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-04-32, b) 41, 44, 47, 50 head, Medium, Item Number 314-04-33, c) 44, 47, 50, 53 head, Large, Item Number 314-04-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-04-35; Shoulder Arthroplasty

Z-1409-2024
Recall number
Z-1409-2024
Initiated
March 06, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Exactech, Inc.
Quantity
39 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH).

Code information

a) Item Number 314-04-32, UDI/DI 10885862199553, Serial Numbers: 2111957, 2161636, 2111956, 2161639, 3755661; b) Item Number 314-04-33, UDI/DI 10885862199560, Serial Numbers: 2112015, 2112016, 2112013, 2112014, 2136760, 2136755, 2424239, 2424237, 2136756, 2424241, 2712715, 3892095, 3892094; c) Item Number 314-04-34, UDI/DI 10885862199577, Serial Numbers: 2111987, 2111986, 2111984, 2138759, 2138757, 2138754, 2138756, 2138755, 2138753, 2425638, 2485901, 2425634, 2138758, 2111985, 2425636, 2425629, 2425627, 2425625; d) Item Number 314-04-35, UDI/DI 10885862199584, Serial Numbers: 2111991, 2430293, 2430292

Distribution pattern

Nationwide and Australia, Austria, Belgium, Brazil, Chile, Canada , China, Colombia, France, Germany, Great Britain, Greece, Guatemala, India, Italy, Japan, Korea, Luxembourg, Malaysia, Netherlands, New Zealand, Portugal, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand

device · product 9 of 24

Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 16o, LEFT, FOR CEMENTED USE ONLY, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-06-22, b) 41, 44, 47, 50 head, Medium, Item Number 314-06-23, c) 44, 47, 50, 53 head, Large, Item Number 314-06-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-06-25; Shoulder Arthroplasty

Z-1410-2024
Recall number
Z-1410-2024
Initiated
March 06, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Exactech, Inc.
Quantity
180 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH).

Code information

a) Item Number 314-06-22, UDI/DI 10885862228307, Serial Numbers: 2579212, 2634987, 2635008, 2579195, 2579206, 2811940, 2811957, 2811935, 2634983, 5718616, 5718644, 5718619, 5933499, 5933502, 5704955, 6756450, 6756452, 5718637, 5933505, 6756441, 6756445, 6756449, 6756455, 5933325, 5933336, 6756451; b) Item Number 314-06-23, UDI/DI 10885862228314, Serial Numbers: 2579171, 2579188, 2635070, 2635068, 2579173, 2635067, 2635101, 2635061, 2635071, 2635064, 2823506, 2823492, 2579179, 2579187, 2635077, 2635078, 2635079, 2635082, 2579172, 4209444, 4209441, 3810131, 2823487, 2811883, 2635086, 2635100, 4209447, 2823504, 2823511, 2635057, 4209454, 3810133, 5247720, 5247712, 5247733, 4209436, 4209451, 5244109, 5247721, 5244110, 5369572, 5600215, 5600216, 5679291, 5369568, 5369563, 5247729, 5369582, 5369569, 5369570, 5369562, 6195298, 5929433, 6611524, 6611529, 6237444, 6195311, 5369578, 5369577, 5369564, 5583201, 6611525, 6611527, 6611530, 6611532, 6237443, 6237446, 6237448; c) Item Number 314-06-24, UDI/DI 10885862228321, Serial Numbers: 2635040, 2579234, 2635025, 2816589, 2816585, 2579228, 2579235, 2579229, 2635020, 2635050, 2635032, 2635039, 2816586, 2823519, 2816606, 2823524, 2579225, 2635016, 2579220, 2635029, 2635047, 2579215, 2816588, 2635035, 2816625, 3876622, 2823533, 2816613, 2823521, 5305367, 5305350, 5600031, 5554824, 5554813, 4209480, 4209466, 3794397, 5305372, 5305361, 5305349, 5753670, 5753659, 5305368, 5554812, 6006578, 5583280, 5305370, 5368871, 5554819, 6006580, 6195255, 6195269, 5753671, 6006579, 6006584, 6612218, 6612226, 6612228, 6612229, 6418445, 6418448, 6612220, 6612222, 6006569, 6195273, 6418446; d) Item Number 314-06-25, UDI/DI 10885862228338, Serial Numbers: 2579243, 2579239, 2823562, 2618355, 2618388, 2618360, 2618398, 3810139, 5718648, 5301843, 5258719, 5730095, 5730085, 6534089, 6534098, 6037827, 6534084, 6534088, 6060453, 6534086

Distribution pattern

Nationwide and Australia, Austria, Belgium, Brazil, Chile, Canada , China, Colombia, France, Germany, Great Britain, Greece, Guatemala, India, Italy, Japan, Korea, Luxembourg, Malaysia, Netherlands, New Zealand, Portugal, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand

device · product 10 of 24

Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 16o, RIGHT, FOR CEMENTED USE ONLY, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-06-32, b) 41, 44, 47, 50 head, Medium, Item Number314-06-33, c) 44, 47, 50, 53 head, Large, Item Number 314-06-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-06-35; Shoulder Arthroplasty

Z-1411-2024
Recall number
Z-1411-2024
Initiated
March 06, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Exactech, Inc.
Quantity
245 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH).

Code information

a) Item Number 314-06-32, UDI/DI 10885862228345, Serial Numbers: 2665747, 2694660, 2694664, 2665744, 2618441, 2694656, 2618425, 2694647, 2811847, 3755779, 2816627, 2823580, 5654258, 5561037, 5369535, 5531306, 6251869, 5654254, 6602367, 6602371, 5654267, 6602366, 6602372, 6251862, 6602374, 6602375, 6602376, 6236784, 6236780; b) Item Number 314-06-33, UDI/DI 10885862228352, Serial Numbers: 2618447, 2618463, 2694637, 2694643, 2618457, 2694624, 2694628, 2816683, 2694627, 2694635, 2816669, 2618455, 3825300, 2823610, 2816679, 2816676, 2823603, 2694641, 2823600, 2665755, 2618460, 2618462, 3755793, 4209645, 2823598, 2694644, 2823595, 2816680, 2816667, 2694642, 2823602, 2816657, 2811751, 2823609, 2816675, 2811760, 3825299, 4209641, 2823605, 2816666, 2816670, 3825291, 2811758, 5305335, 5305330, 5551792, 3825294, 3825307, 4209638, 4209646, 5368875, 5590110, 5933303, 5933313, 5305329, 6195013, 5654283, 6195012, 5305332, 5305314, 5305322, 5551790, 5305337, 6195312, 5933316, 6195317, 6520942, 6520949, 6190106, 6190096, 6190099, 6190109, 6520940, 6520948, 6520936; c) Item Number 314-06-34, UDI/DI 10885862228369, Serial Numbers: 2618486, 2618479, 2618468, 2694559, 2694548, 2694544, 2816686, 2694555, 2618469, 2665763, 2618475, 2665760, 2665757, 2618474, 2618484, 2694553, 2816705, 2816701, 2816704, 2694551, 2694560, 2618476, 2618482, 2665764, 2816706, 2811794, 2823616, 4209654, 2816719, 3856956, 4209663, 2816692, 2811786, 4209656, 2694558, 2816709, 4209664, 2811778, 2694556, 2823620, 2816703, 2694543, 2816690, 4209666, 2823618, 4209669, 2694546, 2823626, 3856953, 2823628, 2823634, 2816712, 2811792, 2823614, 2816696, 2816687, 2811787, 4209661, 2823617, 5305873, 4811744, 4854990, 5305881, 4793714, 5305872, 5272949, 5305870, 5554843, 5554845, 3794406, 3755777, 3856954, 5305894, 5305888, 5753656, 5679293, 5579557, 5554832, 5753642, 5753638, 5369538, 5369540, 5753637, 5305883, 5305892, 5305886, 5554846, 6051510, 6718721, 6718722, 6718718, 6718723, 6718736, 6143299, 6143293, 6143295, 6051513, 5753636, 6051495, 6051583, 6051584, 6718731, 6718732, 5679292, 5753643, 5753650, 6143300, 6143307, 6718726, 6718733; d) Item Number 314-06-35, UDI/DI 10885862228376, Serial Numbers: 2618496, 2618503, 2694849, 2618502, 2618500, 2694863, 2816720, 2816749, 2694861, 2694867, 2694854, 2618489, 2694865, 2811816, 2816733, 2618492, 2823637, 2816742, 4209677, 3755785, 5730064, 3882605, 4209672, 5369463, 6372776, 6372771, 6372775, 6372770, 6372772, 6372778, 6372787

Distribution pattern

Nationwide and Australia, Austria, Belgium, Brazil, Chile, Canada , China, Colombia, France, Germany, Great Britain, Greece, Guatemala, India, Italy, Japan, Korea, Luxembourg, Malaysia, Netherlands, New Zealand, Portugal, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand

device · product 11 of 24

Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; Shoulder Arthroplasty

Z-1412-2024
Recall number
Z-1412-2024
Initiated
March 06, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Exactech, Inc.
Quantity
11031 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH).

Code information

a) Item Number 314-13-02, UDI/DI 10885862172679, Serial Numbers: 2334190, 2334196, 2334178, 2334192, 2334193, 2330945, 2177477, 2177488, 2330864, 2330867, 2177487, 2330948, 2339049, 2452141, 2334179, 2334191, 2177486, 2334180, 2334181, 2334184, 2177485, 2330866, 2330869, 2330863, 2330949, 2330947, 2474424, 2479342, 2334204, 2330950, 2330951, 2334189, 2474441, 2474433, 2177481, 2460075, 2460078, 2177494, 2452137, 2330870, 2334185, 2452125, 2339045, 2339047, 2177484, 2334200, 2334194, 2334202, 2339052, 2177492, 2460068, 2474428, 2474435, 2474440, 2330865, 2541672, 2522113, 2452126, 2622872, 2330946, 2479332, 2479341, 2541668, 2334201, 2622842, 2479331, 2522100, 2622864, 2479325, 2479324, 2615282, 2594866, 2594857, 2334183, 2452142, 2622850, 2615269, 2452130, 2541662, 2334198, 2479346, 2594861, 2339048, 2522106, 2622824, 2622879, 2622818, 2330944, 2615262, 2479333, 2474439, 2622856, 2334182, 2460076, 2460072, 2460067, 2330943, 2460070, 2460071, 2541670, 2452132, 2177490, 2594858, 2622820, 2452138, 2334187, 2339053, 2622873, 2622838, 2622823, 2594860, 2622835, 2615271, 2522095, 2622816, 2460077, 2622826, 2622867, 2334197, 2522109, 2334177, 2622883, 2522105, 2622847, 2479347, 2634054, 2330868, 2474427, 2541663, 2452143, 2594872, 2615261, 2177495, 2622863, 2522111, 2474426, 2622854, 2622839, 2622865, 2522097, 2601953, 2334188, 2622881, 2634058, 2177483, 2634050, 2634053, 2474437, 2479343, 2622840, 2541673, 2622861, 2622855, 2615260, 2541671, 2622845, 2522112, 2339050, 2339044, 2339051, 2634052, 2479336, 2330871, 2460079, 2622817, 2541669, 2615275, 2622860, 2479319, 2615264, 2452136, 2541665, 2479329, 2622827, 2541676, 2452131, 2622834, 2474442, 2615280, 2615277, 2622880, 2479348, 2622825, 2479339, 2622836, 2479320, 2479351, 2334195, 2474423, 2474425, 2479338, 2474434, 2452139, 2594870, 2460065, 2177479, 2177482, 2479345, 2474438, 2622859, 2622837, 2622862, 2622853, 2615268, 2594859, 2622870, 2522108, 2622828, 2522101, 2522102, 2811926, 2700812, 2700821, 2811910, 2700819, 2770310, 2700813, 2770334, 2811984, 2689275, 2811929, 2770324, 2811914, 2811928, 2811978, 2770317, 2770307, 2689272, 2770316, 2770337, 2777060, 2811975, 2770336, 2689265, 2811923, 2811982, 2770303, 2700818, 2777339, 2770301, 2770330, 2777052, 2777342, 2811892, 2811901, 2777340, 2700814, 2770297, 2811919, 2777343, 2700808, 2689273, 2811995, 2811988, 2770309, 2777057, 2700809, 2811899, 2689269, 2700817, 2689270, 2811920, 2777055, 2770306, 2811904, 2811994, 2689276, 2770327, 2770314, 2777344, 2777053, 2777076, 2811970, 2689277, 2811897, 2811900, 2811891, 2811906, 2479323, 2177480, 2622858, 2334175, 2330942, 2474430, 2474429, 2622830, 2594865, 2622843, 2479326, 2622848, 2622819, 2622846, 2452144, 2615273, 2334199, 2460069, 2541664, 2622851, 2622841, 2460074, 2622884, 2634048, 2594869, 2479340, 2622878, 2479344, 2474431, 2622822, 2594863, 2615274, 2594862, 2334203, 2615278, 2594867, 2594868, 2339046, 2634049, 2479327, 2522099, 2594856, 2615266, 2479349, 2622832, 2479330, 2177493, 2615270, 2460073, 2452140, 2479350, 2479317, 2594864, 2893190, 2893189, 2893201, 2969469, 2811911, 2811903, 3556623, 2811922, 2893179, 2893210, 2770302, 2811925, 3588544, 3687003, 2770299, 2777073, 2992533, 2992522, 2992532, 2992544, 2777338, 2992519, 2893197, 3564166, 3636197, 2992503, 3564148, 3623108, 3623262, 3623260, 2914370, 3659299, 3714252, 3623250, 3714255, 2992512, 3636185, 2914401, 3556624, 2992534, 2893199, 2777059, 2770308, 2893188, 3623253, 2770298, 2914375, 2777337, 3636199, 2777068, 2992531, 3564158, 3623242, 3588542, 3636184, 3556620, 3636188, 2777058, 3636179, 3623240, 2992510, 2811979, 3564165, 2811908, 3556633, 2811989, 2992506, 3556638, 3588530, 3556621, 3636195, 3636250, 3659297, 2777062, 3623273, 3588525, 2969477, 2893192, 3636245, 3577208, 3686983, 3577214, 3556622, 2992502, 2969484, 2811976, 2811977, 2811990, 2777078, 2969479, 2770333, 2969487, 2992524, 2992527, 3623244, 3683868, 3683881, 3588539, 2893200, 2893191, 3588528, 2770305, 2893178, 2914394, 2689274, 2811913, 2811985, 2811924, 2777336, 3556636, 2992540, 2777077, 3623232, 3683871, 2811918, 3714277, 2811972, 2992536, 2992517, 3564154, 3588537, 3564155, 2770331, 3683875, 2893206, 2777071, 2893212, 3564151, 3623241, 3588527, 3556628, 3588536, 2811909, 3577203, 2811983, 2811991, 2914396, 2992523, 2811912, 3564152, 3659301, 3659315, 2992546, 3686988, 3686981, 3686980, 2992529, 2770318, 2811898, 2811917, 3564144, 2811902, 3564163, 3588531, 3623141, 2777063, 2992541, 2811980, 2700816, 2811996, 3556625, 3564153, 2969472, 3623233, 3683876, 3683886, 3623249, 3683863, 3588532, 2777075, 3556618, 2770319, 2689266, 2992499, 2914402, 2992515, 3659296, 2969468, 2969486, 2777054, 3564161, 2914378, 3623120, 3714270, 2914372, 3623107, 3577213, 3623239, 2992514, 3556634, 2969476, 3577217, 2914397, 3556635, 3623256, 2992497, 2969470, 3686986, 2777066, 2992528, 2992507, 2893177, 3683867, 3636239, 3636235, 2992509, 2992535, 3623109, 2811993, 2893194, 2811921, 2811986, 2992537, 2811888, 3577215, 3623278, 2969473, 2914379, 2992539, 3686995, 2770315, 3683862, 3588543, 2893202, 3588535, 2811905, 2777056, 2893193, 2770328, 2893198, 3636233, 2700810, 2914399, 3686989, 3686993, 2992545, 3623251, 3636182, 3577216, 3623277, 2893185, 2893180, 3577204, 3588538, 3683864, 2914377, 2777061, 3556630, 2914393, 2969474, 2811907, 3577219, 2777069, 2811890, 2914390, 3564157, 2777072, 3588524, 2992525, 3623248, 3636232, 3636240, 3623246, 3623264, 3683880, 2811974, 3636252, 3636246, 3686994, 2914371, 2914373, 2914381, 2914383, 2914385, 2914395, 3623114, 3636178, 2770326, 3564164, 3623103, 2770320, 3623238, 3636237, 3714286, 3636196, 3623236, 3686996, 3636249, 3556637, 2452129, 2334176, 2452127, 2452128, 2541667, 2615272, 2452133, 2474432, 2479334, 2177478, 2460066, 2634046, 2634059, 2522104, 2522098, 2479337, 3917688, 3917671, 2689268, 3797306, 3636198, 2914386, 3714280, 3910148, 2700815, 4026356, 2914384, 4049202, 3797272, 3868609, 3714242, 3917672, 2770312, 2992508, 4149744, 3683874, 4108638, 2969478, 3714266, 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Distribution pattern

Nationwide and Australia, Austria, Belgium, Brazil, Chile, Canada , China, Colombia, France, Germany, Great Britain, Greece, Guatemala, India, Italy, Japan, Korea, Luxembourg, Malaysia, Netherlands, New Zealand, Portugal, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand

device · product 12 of 24

Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty

Z-1413-2024
Recall number
Z-1413-2024
Initiated
March 06, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Exactech, Inc.
Quantity
12643 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH).

Code information

a) Item Number 314-13-13, UDI/DI 10885862172693, Serial Numbers: 2204820, 2204812, 2204813, 2204815, 2452178, 2500820, 2499638, 2331072, 2427399, 2331064, 2204830, 2336229, 2427393, 2204831, 2204818, 2336244, 2336253, 2336241, 2427397, 2427387, 2499624, 2499632, 2500803, 2336258, 2336245, 2336257, 2406667, 2406673, 2427404, 2427392, 2460064, 2406653, 2499640, 2331078, 2336249, 2336235, 2204821, 2500818, 2204827, 2331062, 2204824, 2204822, 2331068, 2331074, 2406665, 2406664, 2406658, 2452182, 2406650, 2500804, 2452181, 2460057, 2406663, 2406649, 2499625, 2336254, 2427402, 2336230, 2204829, 2204825, 2204814, 2406656, 2336251, 2204816, 2406661, 2204819, 2331077, 2331080, 2331073, 2339033, 2499636, 2331076, 2336252, 2460058, 2406659, 2336240, 2336232, 2204817, 2460062, 2500813, 2665906, 2499647, 2452179, 2562206, 2499637, 2331075, 2562191, 2582335, 2562212, 2562209, 2665770, 2460060, 2500802, 2336256, 2622345, 2204828, 2622349, 2336236, 2406651, 2562189, 2665897, 2499633, 2499652, 2499629, 2582323, 2665785, 2499649, 2499626, 2639486, 2639498, 2427388, 2406646, 2562205, 2622361, 2665766, 2562203, 2609433, 2665778, 2452180, 2622342, 2665794, 2665903, 2665911, 2331061, 2427398, 2499630, 2622336, 2665925, 2665774, 2609430, 2609428, 2609432, 2460061, 2331063, 2500806, 2562186, 2622359, 2665791, 2500816, 2499648, 2460063, 2562202, 2582341, 2582310, 2665921, 2500811, 2427400, 2562207, 2406648, 2427403, 2582339, 2609426, 2609429, 2500819, 2665899, 2665908, 2665783, 2622348, 2331070, 2582332, 2665780, 2562214, 2562194, 2500821, 2460059, 2331079, 2582325, 2622339, 2639508, 2582318, 2665779, 2499627, 2562196, 2336250, 2582313, 2582316, 2499646, 2622356, 2582309, 2665930, 2562187, 2622363, 2639488, 2639482, 2639506, 2639497, 2639479, 2639500, 2406647, 2427395, 2427394, 2582333, 2500814, 2622360, 2665935, 2609427, 2639507, 2500798, 2331069, 2562199, 2562222, 2609425, 2665933, 2639509, 2622353, 2500815, 2582315, 2622338, 2499634, 2639481, 2406670, 2460055, 2499645, 2665768, 2499641, 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Distribution pattern

Nationwide and Australia, Austria, Belgium, Brazil, Chile, Canada , China, Colombia, France, Germany, Great Britain, Greece, Guatemala, India, Italy, Japan, Korea, Luxembourg, Malaysia, Netherlands, New Zealand, Portugal, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand

device · product 13 of 24

Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-22, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-23, c) 44, 47, 50, 53 head, Large, Item Number 314-13-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-25; Shoulder Arthroplasty

Z-1414-2024
Recall number
Z-1414-2024
Initiated
March 06, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Exactech, Inc.
Quantity
3436 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH).

Code information

a) Item Number 314-13-22, UDI/DI 10885862196163, Serial Numbers: 3864575, 4108594, 3864576, 3926687, 4172892, 4155858, 4122466, 4172896, 4108598, 4108597, 4122508, 4257141, 4122477, 3864571, 3926691, 4122529, 3864569, 4268100, 3864580, 4108589, 4122492, 4122459, 4122517, 4268102, 4122497, 3864579, 4268113, 4268120, 4108593, 3926690, 4257162, 4122516, 4268088, 3864568, 4268107, 4257139, 4122504, 4268108, 4257145, 4172899, 5083396, 4967722, 4967725, 4756977, 4730330, 4854762, 4730331, 4854749, 4967732, 4730333, 5077524, 3864581, 4122525, 3864572, 4122475, 4122523, 4268112, 4108599, 4122467, 4122496, 3864578, 4268111, 4250703, 4268097, 4257150, 4257131, 4250699, 4172904, 4108595, 4108600, 3864573, 4268086, 3926688, 4257153, 4087953, 4268091, 4268114, 5501485, 5527443, 5285797, 5285817, 4756975, 4676666, 5527430, 5285799, 5285790, 5285796, 4967729, 5285793, 4854752, 4730315, 4756970, 5077518, 5285814, 5285812, 5083397, 5285826, 4730309, 4122511, 4122470, 4172901, 4122503, 4257151, 4268109, 4122476, 4122522, 4097236, 4172894, 4087954, 4257137, 5501484, 5285789, 4967728, 4730325, 5285823, 4730323, 4854766, 4730311, 4967727, 4854743, 5527434, 4730321, 5527447, 4730327, 4730318, 5077519, 5077522, 5083395, 5501488, 5285798, 5285787, 5285832, 4854747, 4756976, 5501489, 5501492, 5077520, 5077525, 5285806, 4756980, 5285792, 5527438, 5285822, 5285788, 5501486, 4854744, 5285825, 5285824, 5527435, 5285808, 5757909, 5794944, 6059921, 6179544, 5611094, 5757908, 5757895, 6059918, 5848013, 5998799, 5611089, 5941179, 5794934, 5848019, 6059933, 5998800, 5941178, 5897770, 5897772, 6070779, 6179558, 6179566, 5757904, 5611093, 5848014, 5998806, 6059930, 5998803, 5998810, 6059911, 6130500, 6130509, 5757896, 6059915, 5848021, 5848015, 6059926, 5848020, 5897774, 4257140, 4268099, 4268093, 4122506, 4257164, 4122472, 4172905, 4172893, 4257132, 4268110, 4122465, 4257152, 4155860, 4250710, 5501496, 4756984, 5285786, 5285815, 4854753, 4854745, 5501491, 5501497, 5285807, 5501499, 4756972, 4967733, 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6752559, 6863111, 6751359, 6849683, 6755262, 6753070, 6356232, 5795172, 6755265, 6753076, 5845306, 6753046, 6356249, 6641699, 6852343, 6670372, 6715448, 6413703, 6852357, 6289810, 6851765, 5951138, 6289790, 6505368, 6883867, 6037882, 6863120, 6641697, 6883853, 6849688, 6752593, 6883865, 6753081, 6852348, 6989312, 6919351, 6989313, 6919352, 6945609, 6945628, 6989248, 6919374, 6989242, 6989255, 6945613, 6989274, 6919355, 6752588, 6751349, 6753066, 6752564, 6851763, 6755224, 6919349, 6989249; c) Item Number 314-13-24, UDI/DI 10885862200983, Serial Numbers: 3864594, 3864600, 4024294, 4024293, 4041861, 4108623, 4121782, 3926706, 3864602, 3864601, 4024295, 4041860, 4160720, 3864591, 4087946, 3864604, 3849879, 3926709, 3864595, 4121839, 3926708, 4087948, 4108622, 3926705, 3864597, 4121821, 4108624, 4167216, 4160719, 4257096, 4268239, 4121829, 4208662, 4208659, 4121773, 4155845, 4121772, 4121825, 4250652, 4108619, 4140272, 3864592, 4208661, 4208660, 4087949, 4250672, 3864593, 4121768, 4121815, 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6179338, 6829817, 6857116, 6574488, 6392387, 5951129, 6857399, 6342661, 6798662, 6179586, 6680665, 6798661, 6857382, 6448710, 6506205, 6829827, 6130424, 6829815, 5633986, 6798645, 6709388, 5633992, 6448702, 6179346, 6798470, 6574492, 6130411, 6448708, 6709412, 6798474, 6829826, 5633222, 5951093, 6857384, 6198983, 6342672, 6179596, 5937940, 6259659, 6857396, 6709410, 6342646, 6392380, 6799714, 5633199, 5794914, 6080852, 6179349, 6829825, 5633999, 6798456, 6382436, 6798656, 6798642, 6680680, 6680666, 6857400, 6130471, 6461806, 6130444, 6709416, 6130451, 6709382, 6799687, 6130414, 6130455, 6680662, 6829821, 6680681, 6857109, 6709380, 6756528, 5937943, 5619658, 6798658, 6273642, 6392375, 6857088, 6448700, 6857370, 6756535, 6756545, 5633209, 6382433, 7038075, 6977099, 6911622, 6977116, 6977078, 6911625, 7037666, 7038083, 6977068, 7038085, 7037678, 7038065, 7038066, 6977108, 6977083, 6977088, 7038078, 7038073, 7037677, 6977107, 7038074, 7038072, 6977076, 6977091, 6977069, 6977113, 7037667, 6977090, 6977072, 7038067, 6911614, 7038080, 6911609, 6977062, 7037665, 7037670, 6977094, 7037682, 6977095, 7037663, 6977096, 6977120, 5386214, 5539373, 5539386, 6179590, 6715971, 6798477, 6130422, 6392386, 6715958, 6130480, 5951105, 5619678, 5619662, 6342651, 6798458, 6448704, 6392376, 6857106, 6448691, 6857096, 6799713, 6342655, 6392401, 6077172, 6382414, 5633217, 5951130, 6799693, 5937933, 6342675, 5937912, 6857378, 6857085, 6506221, 6798459, 6130469, 6715976, 6179572, 6077167, 5951103, 5633987, 6130461, 6798466, 6448703, 6342657, 6130465, 6198978, 6857111, 7038059, 7037671, 7038084, 7037673, 7037654, 7037664, 7037683, 7037672, 6911617, 7037659, 6179570, 6756534, 6798480; d) Item Number 314-13-25, UDI/DI 10885862200990, Serial Numbers: 3849881, 3864677, 4122170, 3849882, 3948553, 4122154, 4122149, 4122136, 4108757, 4122127, 4263695, 3864670, 4122168, 4263710, 4263653, 3948551, 4122112, 3948560, 4263662, 4263686, 4263707, 4854953, 4122113, 4108760, 3864667, 4263725, 4263709, 4263693, 4263721, 3948556, 4122139, 4122158, 4263733, 4263713, 4766586, 5318544, 4766585, 4757090, 5539392, 5163520, 4982798, 4122125, 4263661, 4263698, 4122134, 4122130, 4263720, 4122144, 3864669, 4263730, 4263649, 4122122, 3864678, 5318531, 4982799, 5163519, 5318522, 5163511, 5318527, 5082472, 4757105, 5163512, 4968404, 5163521, 5163522, 4757098, 5627636, 6133118, 6133104, 4263692, 4108758, 4263696, 4263719, 5539390, 4757092, 5539397, 5318545, 5539396, 5539411, 5318525, 4757104, 5163518, 5318519, 6070764, 6446406, 6598293, 5625096, 6446372, 5851499, 5627659, 5625095, 6081664, 6151692, 6151698, 6291150, 6291153, 4968401, 5082473, 5318547, 5539403, 4757087, 4757089, 6133137, 6806701, 6598310, 6598339, 6881461, 6197098, 6081661, 5625098, 6598316, 6806695, 6081656, 6081649, 6806702, 6446378, 6291148, 5627634, 6133080, 6070759, 6270032, 6598328, 6865143, 6133122, 6133131, 6133115, 5627655, 5318518, 6598302, 6806700, 6881454, 6133095, 6133094, 6133097, 6598281, 6133109, 6820915, 6598283, 6133101, 6820931, 6825072, 6598330, 6820929, 5625097, 6598329, 6598341, 6820932, 6270034, 6197109, 6820922, 6825076, 6820927, 6151704, 6598299, 5627639, 6820956, 6133128, 6820930, 6598346, 6446381, 6446401, 6133111

Distribution pattern

Nationwide and Australia, Austria, Belgium, Brazil, Chile, Canada , China, Colombia, France, Germany, Great Britain, Greece, Guatemala, India, Italy, Japan, Korea, Luxembourg, Malaysia, Netherlands, New Zealand, Portugal, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand

device · product 14 of 24

Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-32, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-33, c) 44, 47, 50, 53 head, Large, Item Number 314-13-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-35; Shoulder Arthroplasty

Z-1415-2024
Recall number
Z-1415-2024
Initiated
March 06, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Exactech, Inc.
Quantity
4007 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH).

Code information

a) Item Number 314-13-32, UDI/DI 10885862201003, Serial Numbers: 3864654, 3864659, 4140193, 4155690, 4257179, 4250984, 4155679, 4140217, 4155678, 3864658, 4108679, 4155704, 4257186, 4257198, 3926702, 4108676, 4257194, 4108680, 3926703, 4155692, 3864663, 3864662, 3864653, 3926698, 4257174, 4108685, 4269883, 4155683, 4257173, 4108681, 4269885, 4269868, 4155685, 4155677, 4269870, 4155700, 4108682, 4108683, 4269898, 4155697, 4140198, 4257180, 4257196, 4269876, 4968395, 4684348, 4684355, 4684340, 4684354, 4808076, 4808075, 4968389, 4757115, 4684353, 4757123, 4808079, 4968386, 5067509, 4808072, 4808060, 4269872, 4257193, 3864650, 4250985, 4108678, 4108684, 4257185, 4250982, 4087951, 4269882, 4140207, 4250976, 4257187, 4269900, 3864657, 4250992, 3926700, 4269873, 4968393, 5088349, 5304460, 5304457, 4808070, 5304512, 4684342, 5304461, 5304479, 4684347, 5304478, 5519088, 5088351, 4684344, 5304475, 5519087, 4968399, 5304477, 5304485, 4684365, 4684350, 5519079, 4757113, 4757124, 5519094, 5304459, 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6689601, 6156652, 6080883, 6064046, 6503127, 6277524, 6080881, 6880712, 5847967, 6823779, 6080873, 6442309, 6689620, 5797685, 6823759, 6666303, 6503130, 7011275, 7011266, 7011270, 7011277, 7011272, 5519080, 5797689, 6821914, 5757448, 5757460, 6821946, 6666323, 6070771, 6880711, 5563437, 6689610, 6198969, 6156636, 6689580, 6880710, 6392154, 6821938, 6821936, 6821922, 6080875, 6503135, 5757447, 6442323, 6198950, 6666305, 6479719, 6277531, 6392161, 6156624, 6156623, 6080893, 6330741, 6689570, 6689606, 6823760, 6821947, 6198962, 6823770, 6666300, 6821926, 6689599, 7011278, 6479694, 6689593, 6442335; b) Item Number 314-13-33, UDI/DI 10885862201010, Serial Numbers: 3864646, 3864636, 3864645, 4024298, 4155286, 4087937, 4140231, 4167217, 3848609, 3848610, 4100422, 4108690, 4100421, 4155283, 4108697, 4155284, 4100425, 3864638, 4024296, 3864644, 3864643, 4108693, 4155281, 3848611, 3864640, 3864641, 4087940, 4087938, 3848612, 4108698, 3926685, 3926680, 3926682, 4251001, 4140241, 3926683, 4224365, 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Distribution pattern

Nationwide and Australia, Austria, Belgium, Brazil, Chile, Canada , China, Colombia, France, Germany, Great Britain, Greece, Guatemala, India, Italy, Japan, Korea, Luxembourg, Malaysia, Netherlands, New Zealand, Portugal, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand

device · product 15 of 24

Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty

Z-1416-2024
Recall number
Z-1416-2024
Initiated
March 06, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Exactech, Inc.
Quantity
11863 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH).

Code information

a) Item Number 320-36-00, UDI/DI 10885862086617, Serial Numbers: 1954421, 1954426, 1954423, 1954422, 1954424, 2084846, 2102178, 2095168, 2085991, 2142641, 2200474, 2200475, 2142642, 2223309, 2276145, 2399592, 2418172, 2418175, 2418174, 2399591, 2223310, 2223311, 2276143, 2276140, 1954425, 2276142, 2418173, 2276144, 2399593, 2399590, 2662625, 2528861, 2528862, 2528864, 3637099, 3673852, 3637100, 3637097, 2662624, 2788819, 2662626, 2788821, 3573735, 3573734, 3616397, 2565880, 2565882, 3616398, 3616399, 3616396, 3637096, 3694392, 2662627, 2823683, 3740075, 3754460, 3758537, 2200473, 2399594, 2276141, 3694390, 3740074, 3694391, 2565878, 3740073, 2823681, 2823684, 3918249, 3918248, 3989825, 3989840, 3827079, 3870844, 3918250, 3989838, 3870840, 3918260, 3870838, 3989830, 3989841, 3918261, 3827096, 3870834, 3870843, 3827084, 4028552, 3827081, 3827091, 3827095, 3827076, 3827094, 3827082, 3827078, 3827087, 3827088, 3827089, 3827097, 3827083, 3827090, 3827093, 3827080, 3918243, 3918247, 3918251, 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5869504, 5870235, 5869006, 5933426, 5869018, 5910071, 5869499, 5870231, 5911041, 5932757, 6190418, 6190426, 5911083, 5869501, 5869502, 5932684, 6027656, 5870033, 5933410, 5933422, 5869015, 5869505, 5910076, 5933433, 6168287, 5975243, 6297095, 5870053, 5869808, 5911054, 5975222, 6044437, 5870049, 5869848, 5911047, 5911037, 6044462, 6190431, 5933477, 5932664, 6264990, 5932736, 5869005, 5932672, 5869029, 5933472, 6027691, 5869022, 6190373, 6259707, 5975016, 6190443, 6246133, 6259696, 5910091, 5869493, 5869829, 6064703, 6064723, 5869000, 5869020, 6190399, 5910092, 5869004, 6168305, 5975122, 6259701, 4371049, 4254127, 4810148, 4707118, 4756193, 4837761, 4959313, 4696475, 5057128, 5040543, 6109031, 6319396, 6090231, 6176720, 6510544, 6207470, 6207430, 6506154, 6512533, 6100046, 6319428, 6319300, 6411945, 6411967, 6506566, 6510608, 6506140, 6246154, 6034436, 6089988, 6506537, 6510560, 6297066, 6506193, 6512513, 6411954, 6543363, 6064652, 6287271, 5869824, 6352074, 6489440, 6342215, 6342216, 6523634, 6510647, 6259730, 6319290, 6264997, 6170018, 6523623, 6512549, 6207289, 6543319, 6110377, 6169760, 6190370, 6190475, 6168324, 6297107, 6100045, 6523421, 6488895, 6523417, 6489407, 6523515, 6510587, 6207438, 6510595, 6510620, 6523495, 6506163, 6523670, 6264901, 6190386, 6259736, 6394525, 6264993, 6264900, 6297061, 6264919, 6207357, 6360339, 6352038, 6352022, 6523338, 6543348, 6489425, 6297063, 6352052, 6264914, 6044440, 6506161, 6190422, 6169878, 6034420, 6169985, 6259737, 6523415, 6319352, 6190393, 6190392, 5932719, 6489426, 6394627, 6169762, 6190462, 6168283, 6064699, 6319351, 6264903, 6190488, 6169880, 6169890, 6297098, 6064717, 6319340, 6506137, 6207323, 6170013, 6297054, 6523339, 6510607, 6319286, 6342253, 6089984, 6246102, 6169983, 6246115, 6297114, 6394635, 6319303, 6027801, 6352090, 6506559, 6246111, 6523464, 6510552, 6512534, 6523662, 6512523, 6506555, 6523674, 6523490, 6506169, 6168328, 6168329, 5869818, 6168353, 6190416, 6190414, 6319349, 6394523, 6512528, 6523465, 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6510585, 6510659, 6088947, 6064710, 6506535, 5869683, 6259710, 6287252, 6100060, 6190483, 6319404, 6207422, 6276314, 6190484, 6169914, 6342230, 6510542, 6510630, 6246126, 6207339, 6246104, 6488899, 6506175, 6506534, 6506194, 6523633, 6523327, 6246151, 6176713, 6297068, 5974986, 6523425, 6523666, 6064660, 6109032, 6360320, 5911046, 6543351, 5870039, 6246143, 6090251, 6246124, 6259711, 6168279, 6246109, 6510559, 6523655, 6168274, 6345411, 6394661, 6169913, 6190381, 6276294, 6276305, 6394642, 6276297, 6352092, 6345424, 6319385, 6488953, 6190468, 6512496, 6523635, 6510556, 6523680, 6489446, 6510548, 6352076, 6169909, 6506142, 6169749, 6512507, 6287256, 6034411, 5974866, 6064648, 6207293, 6342211, 5869816, 5910008, 6352103, 6411971, 6207287, 6394655, 6246160, 6360334, 6523438, 6506523, 6510602, 6510596, 6512525, 6488897, 6523660, 6297127, 6027643, 6319343, 6411952, 6297121, 6543366, 6264984, 6352105, 6064726, 6319307, 6510558, 6319292, 6489417, 6287263, 6319291, 6512495, 5870047, 6345423, 6176715, 6168295, 6027793, 6523505, 6543388, 6523646, 6089976, 5932743, 6523413, 6190450, 6488927, 6259704, 6169980, 6394529, 6523499, 6489429, 6523664, 6169767, 6342254, 6044453, 6207447, 6319358, 6394562, 6506552, 6543342, 6027629, 6543373, 6523640, 6190390, 6176716, 6246156, 6100056, 6168269, 5975119, 5974966, 6207300, 6207373, 6207372, 6319282, 6259731, 6352083, 6207376, 6297124, 6259724, 6352037, 6259732, 6259725, 6506139, 6523427, 6523516, 6489453, 6506528, 6512503, 6190486, 6543312, 6543327, 6543324, 6207324, 5974985, 6064707, 6276317, 6064669, 6207437, 6352031, 6352069, 6510583, 6287264, 6488903, 6319372, 6523508, 6512532, 6190384, 6319386, 6523638, 6287250, 5870048, 5932726, 6319322, 6319339, 6512546, 6190423, 6543357, 5932738, 6342237, 6319327, 6207456, 6100047, 6259706, 5932722, 6319395, 6411968, 6319369, 6488926, 6190424, 6512493, 5974973, 6100051, 6027687, 6489447, 6264996, 6319424, 6352080, 6168366, 6027683, 6207318, 5933434, 5974850, 6207429, 6176722, 6510575, 6090228, 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6207313, 5975135, 5870043, 6489399, 6207297, 6168337, 6105321, 6489436, 6489403, 6190407, 6319368, 6345404, 6506152, 6510554, 6207352, 6246114, 6027625, 6170000, 6510599, 6207364, 6510636, 6168341, 6394659, 6190391, 6506532, 6523675, 6352082, 6170025, 6044214, 6168364, 5932727, 6543340, 6169917, 6512518, 6360316, 6489451, 6095960, 6510604, 6190490, 6264880, 6506557, 6523629, 6190389, 6190456, 6394657, 6394554, 6411961, 6176724, 6342207, 6488904, 6506151, 6512540, 6506146, 6090223, 6543318, 6027810, 6319416, 5933446, 6352081, 6089994, 6394557, 6510600, 6523663, 6190446, 6411953, 6297093, 6523628, 6523507, 6064828, 6190430, 6510617, 6342256, 6523637, 6352030, 6319418, 6394586, 6512509, 6543337, 6190371, 6207457, 6169978, 6264994, 6319409, 6169899, 6090234, 6506150, 6064825, 6510640, 6345406, 6044198, 6044434, 6176734, 6207348, 6319313, 6190421, 6259729, 6510612, 6512522, 6190485, 6246113, 6259712, 6319324, 6360317, 6512537, 6287164, 6510590, 6506521, 6168321, 6319421, 6287274, 6489396, 6512547, 6169904, 6169765, 6259740, 6287261, 6027662, 6523658, 5933479, 6510632, 6345418, 6523510, 6411943, 6506562, 6506191, 6170021, 6506539, 6207476, 6034417, 6190420, 6523497, 6506159, 6510656, 6510541, 6265001, 6044457, 6411958, 6488942, 6523661, 6168336, 6176709, 6352020, 6489408, 6168277, 6034418, 6394559, 6543338, 6287262, 6190375, 6506519, 6287162, 6319403, 6394534, 6394654, 6345422, 6512508, 6543382, 5933460, 5975017, 6264995, 6176731, 6168309, 6027815, 6207292, 5910089, 6315778, 6095956, 6246120, 6342218, 6345410, 6170023, 6207431, 6488898, 6489430, 6489410, 6523411, 6512497, 6360335, 6510654, 6543375, 6523477, 5974987, 6510626, 6297111, 6297116, 6259726, 6506179, 6510614, 6360329, 6523681, 6287163, 6512531, 6170003, 6287172, 6342217, 6169998, 6190481, 6506171, 6506189, 6506192, 6512492, 6512499, 6512504, 6512512, 6512520, 6512527, 6512530, 6512545, 6411948, 6411965, 6246118, 6246119, 6264882, 6264883, 6264885, 6264886, 6264887, 6264888, 6264889, 6264891, 6264892, 6264894, 6264895, 6264896, 6264904, 6207290, 6207291, 6207299, 6207301, 6207326, 6207327, 6207332, 6207419, 6207433, 6207436, 6207341, 6207349, 6207439, 6246105, 6246106, 6246108, 6246117, 6246128, 6246129, 6259727, 6319370, 6319371, 6319373, 6319374, 6319377, 6319378, 6319380, 6319384, 6319390, 6319393, 6394509, 6394510, 6394511, 6394514, 6394520, 6394521, 6394522, 6394530, 6394531, 6259739, 6259742, 6259743, 6259745, 6259746, 6259747, 6259748, 6259749, 6273241, 6273242, 6273246, 6273247, 6273248, 6273252, 6273253, 6273255, 6273256, 6273257, 6273258, 6273259, 6273260, 6273261, 6273262, 6273264, 6273265, 6273266, 6319346, 6319347,

Distribution pattern

Nationwide and Australia, Austria, Belgium, Brazil, Chile, Canada , China, Colombia, France, Germany, Great Britain, Greece, Guatemala, India, Italy, Japan, Korea, Luxembourg, Malaysia, Netherlands, New Zealand, Portugal, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand

device · product 16 of 24

Exactech Equinoxe REVERSE SHOULDER,36mm Constrained Humeral Liner: a) +0mm, Item Number 320-36-10, b) +2.5mm, Item Number 320-36-13; Shoulder Arthroplasty

Z-1417-2024
Recall number
Z-1417-2024
Initiated
March 06, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Exactech, Inc.
Quantity
826 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH).

Code information

a) Item Number 320-36-10, UDI/DI 10885862086631, Serial Numbers: 2608259, 2878175, 3759662, 3759663, 3810144, 3810149, 3786337, 3872525, 3872529, 3872524, 3872528, 3872526, 3872520, 3872535, 3872523, 3872539, 3872521, 3872534, 3872533, 3872537, 3872522, 2608258, 3872538, 3872536, 4124979, 4124982, 4124983, 4124978, 4291229, 4291226, 2878177, 4291213, 4124977, 4291230, 5027717, 3786334, 3872527, 4888837, 4888833, 5027713, 4988489, 4988487, 5027718, 4888828, 5165724, 5165727, 5165729, 4291218, 4291227, 3872531, 4291221, 4291228, 4291234, 4291225, 4291220, 5027706, 5027712, 5165730, 4696503, 4794697, 4696499, 4794698, 5165725, 4794699, 5869637, 5874634, 5869433, 5874635, 5869631, 5874638, 5869472, 5874626, 5909270, 5869429, 5869638, 5869450, 6167632, 5909268, 5869418, 5869422, 5909261, 5909266, 4291209, 4291231, 4794696, 5165722, 4988486, 4888836, 5869629, 6105291, 5869630, 6167625, 6023991, 6167650, 5869439, 6167646, 6522758, 6167637, 6190136, 6105269, 5869425, 6105281, 6064916, 6049281, 6167628, 6167644, 6190164, 6411847, 6190200, 6190139, 6049285, 6064914, 6008302, 5869475, 6044055, 6064921, 6064918, 6190229, 6167627, 6167652, 6190176, 6044060, 6190216, 5909259, 6105292, 6190171, 6522745, 5874639, 6553343, 6553295, 6593394, 6418061, 4988494, 4988493, 5869463, 6522759, 6008270, 6008278, 6522764, 6167648, 6167653, 6167630, 6044056, 5869443, 6008301, 6190135, 6008265, 6064908, 6008276, 5869437, 6483972, 6522742, 6167643, 6167611, 6008287, 6522768, 6023885, 6483986, 6008291, 6411835, 5869420, 5869459, 5869444, 6483966, 6190166, 6023973, 6167642, 6008283, 6190219, 6522770, 6105276, 5869438, 5869417, 6522731, 6190224, 6522761, 6023984, 6105289, 6190168, 5909267, 6008258, 6190198, 6190162, 6484020, 6394867, 6394854, 6167615, 6522744, 6064928, 6008290, 6190163, 6522779, 6167655, 6522736, 6008300, 6008256, 6023894, 6190126, 6049286, 6105267, 6044053, 6064915, 6064905, 6483973, 6105294, 6008284, 6522771, 5869435, 6008310, 5874636, 5874617, 6167612, 6418069, 6553339, 6418077, 6418072, 6713228, 6553334, 6418059, 6593370, 6553333, 6567052, 6713255, 6553293, 6593369, 6713249, 6713194, 6713221, 6593399, 5165721, 4988492, 5027709, 4988488, 6411842, 6190175, 6023902, 6483950, 6167620, 5869428, 6483951, 6483984, 6484005, 6044057, 6008296, 6411833, 6049283, 6167657, 6483976, 6190145, 6064912, 5869454, 6105266, 5874610, 6105280, 6483959, 6483991, 5869453, 6023981, 6484006, 6105295, 6483982, 6394881, 5869639, 6023890, 6394883, 5874615, 6044063, 6167641, 5869452, 6023982, 6023889, 6044064, 6483971, 6411843, 6008308, 6008279, 6167619, 6484007, 6394869, 6190227, 6190124, 6411846, 6064923, 6483983, 6008257, 5909260, 5909274, 6008269, 6023887, 6105265, 6190230, 6008294, 6190209, 6064920, 6064906, 6023972, 6105287, 6167636, 6008299, 6008251, 6522777, 6008262, 6167618, 6190161, 6023983, 6064910, 6023886, 6049288, 6394878, 6190148, 6190228, 6418064, 6713252, 6713211, 6713251, 6713239, 6713207, 6593443, 6418066, 6553342, 6713209, 6418060, 6553321, 6713210, 6713219, 6713232, 6593430, 6593368, 6593393, 6593415, 6553288, 6593387, 6593450, 6593439, 6418056, 6553344, 6567042, 6567053, 6553311, 6713227, 6713222, 6593423, 6713248, 6713244, 6567027, 6593410, 6593385, 6167614, 6023988, 6411841, 6394874, 5874618, 5869462, 6105282, 6190137, 6484000, 6483981, 6190220, 6394876, 6008280, 6483953, 6522739, 5869440, 6190150, 6008263, 6008254, 6023893, 6008289, 5869446, 6190199, 6484010, 6190214, 6044062, 6064929, 6484016, 6483980, 6105286, 6190206, 6190218, 6190194, 5869632, 6008306, 6008309, 5869423, 6484009, 6023979, 6411837, 6190128, 6167645, 6522737, 6394865, 6008271, 6008307, 6484017, 6049287, 6190179, 5869432, 6190207, 6190191, 6190195, 6008268, 5909258, 6049282, 6522773, 6484015, 6190203, 6522786, 6483998, 5909277, 6713203, 6418067, 6567060, 6567044, 6553318, 6567037, 6713193, 6593447, 6553325, 6593432, 6593438, 6593383, 6593377, 6713218, 6553303, 6593431, 6593451, 6418071, 6713215, 6713235, 6567047, 6713229, 6553291, 6593375, 6713240, 6418076, 6064932, 6190133, 6044046, 6064919, 6713234; b) Item Number 320-36-13, UDI/DI 10885862086648, Serial Numbers: 1954420, 2256738, 3758542, 3758543, 3800198, 3800191, 3800197, 3800200, 3800207, 3800203, 4018906, 2668553, 3758540, 3758541, 4113875, 4113876, 4425495, 4425498, 4078885, 2668555, 4679675, 4806827, 5035254, 5062750, 4113874, 4425500, 4113873, 4968116, 4679689, 5062753, 5062744, 4806821, 4679673, 5223272, 5223271, 4968117, 5062749, 5223259, 4806818, 5062745, 4806826, 5062747, 5223260, 5223277, 4679677, 4679681, 3800190, 3800202, 4806819, 5223263, 5223273, 4968121, 5062752, 4679674, 4968118, 5223261, 5223257, 5910702, 6168427, 5937181, 5910526, 5910715, 5937185, 5937159, 6007601, 5869649, 5869650, 5910710, 5910716, 4888945, 4673785, 5223255, 5223269, 5223268, 5223267, 4679685, 5910699, 6044092, 6044086, 6484059, 6168462, 6168458, 6542083, 6169849, 6007574, 5910527, 6062073, 6007609, 6168457, 6023085, 5910529, 6484067, 6007605, 6023087, 6022405, 5910705, 6189457, 6189453, 6502660, 6189442, 6542098, 6007597, 6189439, 6484068, 6007584, 6007573, 6189412, 5910720, 6189461, 6007589, 5937179, 6023099, 6484080, 6062089, 6189465, 5869645, 6168452, 6170395, 6007577, 6007621, 6189429, 5910724, 6542101, 6502664, 6170383, 6170385, 6170403, 6170407, 6170408, 5910515, 6007588, 6553391, 6460537, 4425497, 5035248, 5035251, 4679682, 5035257, 6170390, 6007596, 6484052, 6044082, 6023083, 6189416, 6538322, 6484066, 5910524, 6044081, 6189432, 6007626, 6170421, 6484106, 6484109, 6502654, 6022397, 6170417, 6023088, 6538344, 6170386, 6022381, 6484112, 6484079, 6007599, 6168453, 6007619, 6170392, 6007627, 6044080, 6007578, 6538334, 5910514, 6538323, 6044066, 6502666, 6484120, 6220198, 6168441, 6168443, 5910531, 6189408, 5937164, 5910718, 6484100, 6168419, 6502657, 6023097, 6007616, 6168430, 6044068, 6170409, 6168420, 6484108, 6170398, 6484121, 6484087, 6542108, 6169857, 6553352, 6553378, 6554480, 6460534, 6553359, 6554518, 6554520, 6553392, 6553348, 6553345, 6553372, 6460546, 6554509, 6460552, 6554516, 6554523, 6554496, 5035249, 5062742, 5223258, 6189420, 6220183, 5910697, 6170387, 6007598, 5910709, 6542111, 6189426, 6007586, 6538347, 6168450, 6502646, 6044089, 6007590, 6484117, 6169851, 6022398, 6062079, 6220199, 6044078, 6189419, 6538330, 6168423, 6484064, 6168436, 6169847, 6502663, 6538332, 6484089, 6022378, 5937176, 6220190, 6189407, 6170425, 6189404, 6007587, 6170401, 6220195, 6007572, 5910530, 5910723, 5910519, 6542087, 6169860, 6169859, 6044077, 6538337, 6189451, 6542110, 6044091, 6022389, 6484091, 6542088, 6484050, 6484101, 5910711, 6484086, 6022388, 6022394, 6502659, 6189418, 6062085, 6007610, 6502649, 6484072, 6593340, 6593318, 6553350, 6554466, 6593360, 6593343, 6554473, 6554494, 6553374, 6553375, 6554505, 6553390, 6554476, 6554512, 6553371, 6553368, 6460536, 6553369, 6553373, 6554528, 6593365, 5910695, 6168461, 6484119, 6220184, 6220186, 5937178, 6168456, 6007617, 6484076, 6538351, 6170412, 6220182, 6169867, 6189459, 5910701, 6007603, 6484102, 6502655, 5869647, 6168445, 6538340, 6044085, 6007592, 6484122, 6170405, 6170384, 6168446, 6189403, 6189444, 6170394, 6062088, 6170389, 5910534, 5937172, 6007629, 6542097, 6170397, 6189425, 6542086, 6542099, 6044067, 6007634, 5910520, 5910538, 5937189, 6170391, 6189421, 6189435, 6007614, 5910700, 6484118, 6220177, 5910521, 6538335, 6538350, 6022396, 6189414, 6554515, 6593341, 6553363, 6593339, 6554525, 6554467, 6554501, 6593336, 6612243, 6460563, 6554502, 6553347, 6553358, 6711775, 6593363, 6460549, 6593332, 6460551, 6593351, 6711782, 6554526, 6044072, 6170410, 6022399, 6542093, 6542107

Distribution pattern

Nationwide and Australia, Austria, Belgium, Brazil, Chile, Canada , China, Colombia, France, Germany, Great Britain, Greece, Guatemala, India, Italy, Japan, Korea, Luxembourg, Malaysia, Netherlands, New Zealand, Portugal, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand

device · product 17 of 24

Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty

Z-1418-2024
Recall number
Z-1418-2024
Initiated
March 06, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Exactech, Inc.
Quantity
66646 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH).

Code information

a) Item Number 320-38-00, UDI/DI 10885862086655, Serial Numbers: 0983038, 0983044, 0983058, 1033005, 1034649, 0983051, 1032990, 1032983, 1032992, 1092744, 1092666, 1092747, 1030253, 1092653, 1092748, 0983081, 1032991, 1034629, 1034621, 1092680, 1030248, 1032986, 1032994, 1034627, 1092678, 1034630, 1034619, 0983085, 1032998, 0983043, 1092651, 1087764, 0983049, 1034639, 1030256, 0983074, 1034645, 1092655, 1092661, 1092669, 0983066, 1033002, 1034625, 1034623, 1034607, 1034609, 1034601, 1092636, 0983047, 1030255, 1032997, 1092771, 0983042, 1032995, 0983060, 0983075, 0983056, 0983063, 0983039, 0983079, 0983061, 1030257, 0983077, 0983037, 1030254, 1032987, 1033004, 1033000, 1032988, 0983045, 1033003, 1034605, 0983035, 1034648, 1092780, 1092769, 0983067, 0983068, 0983083, 0983048, 0983055, 1030249, 1030258, 1030250, 0983084, 1033006, 1092675, 1092649, 0983040, 0983070, 1032984, 0983053, 1032999, 1034650, 1092743, 1092741, 1092776, 1092767, 1034640, 1092751, 1034638, 1092752, 0983086, 0983073, 0983072, 1034602, 1034611, 1034646, 1034622, 1092663, 1034634, 1092643, 0983059, 1034620, 0983050, 1034610, 1034651, 1034644, 1092770, 1034633, 1034643, 1034626, 1092749, 1092765, 1092762, 1092750, 0983034, 0983076, 0983069, 0983071, 1033001, 1087767, 1092772, 1092633, 0983057, 0983062, 0983080, 0983046, 1092774, 0983078, 1032989, 1034642, 1032996, 1034624, 1030252, 1034631, 1092673, 1092648, 1092668, 1030251, 1032985, 1034647, 1092753, 1092640, 1092642, 1092738, 1092758, 0983041, 1034635, 1034615, 1034614, 1034636, 1034641, 1087765, 1092742, 1092759, 1092763, 1032993, 0983054, 1092658, 1034617, 1092671, 1092662, 1092779, 1092737, 1034618, 1092775, 1092667, 1092656, 1092639, 1092676, 1030259, 1092746, 1034613, 1092681, 1092672, 1092645, 1034616, 1034632, 1034612, 1034603, 1092674, 1092682, 0983036, 1092635, 1092659, 1092647, 1087766, 1034628, 1092670, 1092638, 1092782, 1092757, 1092754, 1034608, 1092641, 1092736, 1092665, 1092783, 1092644, 1092657, 1034600, 1092777, 1092760, 1092778, 1092679, 1092740, 1092664, 1092755, 1092773, 1092677, 1092745, 1092735, 1092650, 1092637, 1092768, 1092781, 1092764, 1092660, 1092766, 1092756, 1092652, 1034637, 1092646, 1092739, 0983064, 1092634, 1195583, 1195595, 1195572, 1164796, 1164795, 1164797, 1195578, 1195575, 1195579, 1164829, 1164786, 1164833, 1164803, 1164812, 1195584, 1164787, 1164817, 1195623, 1195589, 1164800, 1195587, 1164798, 1195600, 1164794, 1195585, 1195577, 1164791, 1164815, 1195602, 1195605, 1164792, 1164826, 1195576, 1195622, 1164799, 1164831, 1195609, 1195617, 1164824, 1195610, 1195606, 1164788, 1164816, 1195588, 1195611, 1164810, 1195607, 1195581, 1195582, 1195614, 1164835, 1164825, 1164808, 1195616, 1164834, 1195594, 1195586, 1164823, 1164832, 1195615, 1164789, 1164830, 1195593, 1195612, 1164821, 1164819, 1164793, 1164822, 1195621, 1195599, 1164802, 1164805, 1164813, 1195598, 1164818, 1195601, 1195620, 1164827, 1164807, 1195625, 1164804, 1164801, 1164806, 1164811, 1164828, 1164820, 1195597, 1195604, 1195608, 1195619, 1195624, 1195592, 1195596, 1195603, 1195613, 1195573, 1247966, 1250354, 1247936, 1247953, 1330475, 1355395, 1204472, 1247972, 1250426, 1330497, 1330491, 1247905, 1247919, 1250380, 1250447, 1330516, 1204427, 1204372, 1204390, 1204375, 1204434, 1247922, 1204420, 1250434, 1250402, 1250398, 1247990, 1330474, 1204438, 1250355, 1247899, 1330550, 1204467, 1247970, 1204439, 1204441, 1330492, 1204459, 1204378, 1250381, 1250449, 1250429, 1247931, 1250385, 1204415, 1204437, 1204383, 1204483, 1250421, 1204444, 1250397, 1204465, 1204448, 1247892, 1250386, 1204431, 1250369, 1204371, 1247917, 1250403, 1250358, 1247904, 1355432, 1356315, 1355437, 1250422, 1204396, 1247951, 1250440, 1247985, 1330452, 1250351, 1330538, 1250419, 1330517, 1250392, 1390456, 1204414, 1247941, 1330471, 1247893, 1204423, 1204419, 1330478, 1204435, 1330485, 1247911, 1204384, 1204447, 1247909, 1204386, 1204473, 1247984, 1250359, 1330507, 1247973, 1250430, 1355421, 1250356, 1204456, 1247957, 1250424, 1250378, 1247927, 1330549, 1204430, 1204449, 1250448, 1250439, 1330488, 1247974, 1250431, 1247975, 1204403, 1204377, 1250437, 1356281, 1356299, 1356321, 1330543, 1356298, 1250400, 1250391, 1250406, 1250411, 1355407, 1356290, 1390409, 1204381, 1204387, 1204484, 1204376, 1247890, 1204429, 1247996, 1250432, 1250374, 1250382, 1250401, 1250418, 1204401, 1250415, 1247932, 1330496, 1330513, 1204428, 1330528, 1356324, 1356312, 1250409, 1204408, 1250399, 1250345, 1250349, 1250413, 1250420, 1247910, 1250412, 1250405, 1247956, 1355406, 1250436, 1356276, 1204373, 1204468, 1330483, 1330472, 1247971, 1247903, 1204460, 1250444, 1330546, 1250367, 1330510, 1330521, 1204412, 1330544, 1247993, 1356304, 1250428, 1330453, 1250433, 1330545, 1247969, 1204391, 1247908, 1250451, 1330501, 1330500, 1356277, 1204421, 1204480, 1204479, 1356284, 1250404, 1247898, 1355438, 1247895, 1330504, 1250377, 1204450, 1204425, 1247912, 1247995, 1247991, 1355384, 1247902, 1247888, 1356279, 1247925, 1247950, 1330490, 1250372, 1247934, 1247976, 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Distribution pattern

Nationwide and Australia, Austria, Belgium, Brazil, Chile, Canada , China, Colombia, France, Germany, Great Britain, Greece, Guatemala, India, Italy, Japan, Korea, Luxembourg, Malaysia, Netherlands, New Zealand, Portugal, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand

device · product 18 of 24

Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty

Z-1419-2024
Recall number
Z-1419-2024
Initiated
March 06, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Exactech, Inc.
Quantity
7213 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH).

Code information

a) Item Number 320-38-10, UDI/DI 10885862086679, Serial Numbers: 0982088, 0982095, 1035622, 0982086, 1035885, 0982078, 1035878, 1035894, 1036369, 1036373, 1013872, 1013887, 1035623, 1035875, 1035880, 1035881, 1035883, 1119110, 1119136, 1119124, 1119130, 1119144, 1119109, 1119104, 1119123, 1119128, 1119129, 1119146, 1036368, 0982100, 1013871, 1013874, 1074102, 1035619, 1013884, 1035629, 1074121, 1035889, 1035876, 1036374, 1074138, 1035893, 1013886, 1035624, 1074108, 1074122, 1074127, 1074128, 1074139, 1035882, 1036366, 0982084, 1374085, 1119094, 1119102, 0982089, 0982081, 1074131, 0982101, 1036359, 1036364, 1074120, 0982087, 1074147, 1074109, 1442856, 1416801, 1416805, 1374050, 1545547, 1374052, 1416803, 1545546, 1374079, 1374342, 1374339, 1374347, 1416802, 1374077, 1374355, 1416811, 1505058, 1505060, 1442866, 1505054, 1516382, 1516384, 1374351, 1505050, 1516381, 1374043, 1516390, 1119121, 1119127, 1119119, 1119145, 1119098, 1119143, 1074119, 0982090, 1074137, 1013878, 1036365, 1074146, 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Distribution pattern

Nationwide and Australia, Austria, Belgium, Brazil, Chile, Canada , China, Colombia, France, Germany, Great Britain, Greece, Guatemala, India, Italy, Japan, Korea, Luxembourg, Malaysia, Netherlands, New Zealand, Portugal, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand

device · product 19 of 24

Exactech Equinoxe Humeral Liner: Item Numbers: a) 320-40-00, b) 320-40-03; Shoulder Arthroplasty

Z-1420-2024
Recall number
Z-1420-2024
Initiated
March 06, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Exactech, Inc.
Quantity
2806 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH).

Code information

a) 320-40-00, UDI/DI 10885862535030, Serial Numbers: 6173429, 5867573, 6007454, 6007478, 5927587, 6008225, 6007520, 5927562, 5927516, 5927575, 6197331, 6196344, 5867550, 5927586, 6196429, 5876444, 6196833, 5867568, 6174559, 5927640, 5927642, 6007467, 6173432, 5927563, 5876441, 6007452, 5876427, 5927631, 6196359, 5867564, 5927584, 5876450, 5927635, 6007456, 5927569, 6007567, 6196425, 6196773, 6173418, 5867565, 6196355, 6173443, 6196769, 6196776, 6196770, 6008226, 6007514, 6196351, 6196366, 5876433, 5876423, 6196505, 6174554, 5867558, 5927521, 6196424, 5927565, 5927591, 6173436, 6007475, 6007480, 6174553, 6008237, 6008243, 6196419, 6007548, 5927483, 6008351, 6174566, 5927485, 6196445, 6196433, 5867562, 5867567, 5876432, 5927498, 5876437, 5867556, 5927608, 5876430, 5876451, 5927561, 6008344, 6007543, 5927510, 6196364, 6196530, 6007568, 6196525, 6173428, 6196357, 5867557, 6196422, 6174552, 5876434, 5927543, 6173442, 6173434, 5927564, 6007465, 6196517, 5927530, 5927532, 6008346, 6196353, 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6646037, 7035348, 7035340, 7021988, 6978986, 7035368, 7021946, 7021818, 7035341, 6668475, 7021827, 6978998, 6572699, 7047473, 6552375, 6671707, 6668457, 7035375, 6979079, 6775122, 6671698, 6563071, 6646099, 6979062, 7035330, 6978992, 6775157, 7035355, 7047517, 6572879, 6622479, 6775142, 6561765, 6671724, 7021806, 6552898, 7047515, 6683081, 6775136, 6668466, 7021955, 6572886, 6552368, 7021815, 6668501, 7047466, 7021794, 6979075, 7021960, 7021792, 6552377, 6572701, 6978995, 7021829, 6561749, 6979093, 6979065, 6671753, 6572712, 6970792, 7021793, 6979042, 7021980, 6646039, 7021813, 7021816, 7021833, 7021804, 6668439, 6979053, 6672779, 6978990, 7035360, 6671745, 6668471, 6978991, 7047483, 6561770, 6671710, 6542592, 6007549, 6173422, 5927529, 6196421, 6543404, 7035373, 6979081, 6979066, 7021976, 6572877, 6979048, 7021939, 6671703; b) 320-40-03, UDI/DI 10885862535047, Serial Numbers: 5910013, 5910544, 6176692, 6168221, 5933375, 5932710, 5910540, 6176689, 6176705, 5932700, 5910546, 6170253, 6168239, 6168242, 6168231, 5910030, 6176686, 5910541, 5933351, 5910011, 5932804, 6176684, 5932796, 5932716, 5933391, 5932701, 5932782, 5933401, 6176688, 5932793, 5932645, 6168245, 5910015, 6168249, 6168251, 5933381, 5910021, 5932717, 5910023, 6170225, 6168230, 6168402, 5910033, 5910018, 5933356, 5933360, 6168228, 6168243, 6168261, 6168267, 6170227, 6176666, 6168380, 6168409, 6168411, 6413497, 6397898, 5910551, 5932789, 6168224, 6168226, 6397830, 6527360, 6176676, 6535182, 6538379, 6535206, 6535179, 6527446, 6397822, 6176690, 6168214, 6168399, 6170254, 6351454, 6527393, 6527375, 6397813, 6527438, 5932792, 6527404, 5933377, 5932632, 5932639, 5932784, 5932698, 6168257, 5933354, 6170237, 6538362, 6397836, 5933355, 6176682, 6170235, 6397828, 5910038, 5932703, 5932695, 5932648, 5933406, 5932714, 6351444, 5910558, 6527371, 6176693, 6176665, 6351446, 6351451, 6176696, 6335152, 6170246, 6397827, 6527410, 6527395, 6170209, 5910022, 6168218, 6397810, 5933364, 6168384, 6170255, 6351441, 5910553, 5933366, 6351453, 6168389, 5933626, 5932707, 6176674, 6397860, 6397858, 6168385, 6168412, 6397865, 5910559, 6535166, 6170219, 5932646, 5932633, 5910032, 6397863, 6527418, 5932791, 6168215, 6168404, 6535185, 6538384, 6535199, 6538372, 5910036, 6397842, 5933365, 6170232, 5910010, 5933353, 6170228, 6170233, 5933374, 6397857, 6527310, 6170216, 6538367, 5933392, 6527388, 5932688, 6535202, 6168417, 6170236, 6397840, 5932797, 6535187, 6168401, 6170256, 6176704, 6335157, 6397877, 6527295, 6535169, 6535198, 6397829, 5910026, 5932787, 6168392, 6168394, 6176673, 6527434, 5932641, 6168255, 6176664, 6170252, 6168253, 6397831, 6168415, 5932693, 6527396, 6397809, 6168391, 6168250, 6168373, 6351450, 5910017, 6397851, 5932647, 6535177, 6397835, 6170229, 5933362, 5910009, 5932715, 6538375, 6351435, 5933357, 5932798, 6538369, 6170248, 6170221, 6170251, 5910550, 6535186, 5933403, 6335155, 5932699, 6527442, 6397871, 6397881, 5932705, 6538385, 5932653, 6176695, 6535163, 6527421, 6168219, 5910019, 6397824, 6397837, 6397846, 6397880, 6535167, 6535170, 6535178, 6527294, 6527298, 6527299, 6527317, 6527328, 6527331, 6671489, 6622528, 6674049, 6609123, 6575875, 6609111, 6575870, 6575872, 6575934, 6413491, 6527385, 6168238, 6527398, 6538361, 6527415, 5910549, 6535205, 6351459, 6527376, 6351452, 6170230, 6535181, 6170211, 6170247, 6413492, 6527431, 6527364, 6176677, 6351433, 6168377, 6527333, 6538382, 5932651, 6168263, 6397891, 6168241, 6535168, 5933394, 6538354, 6527401, 5933361, 6527403, 5932656, 6168386, 6397811, 6535172, 5932713, 6538383, 5933402, 6527414, 6176669, 6538386, 6527334, 6176681, 6527412, 5932788, 6527339, 6527343, 6527313, 6527314, 5932790, 5933376, 5932780, 6527296, 6527324, 6527308, 6168260, 6397890, 6535160, 6535165, 6168265, 6527392, 6538357, 6168244, 6535189, 6397843, 6397832, 6168407, 6168371, 6168233, 6170212, 6527318, 6538371, 6527348, 6397868, 6397845, 6170208, 6351439, 5910035, 6170240, 6168396, 6538353, 5933387, 5932708, 6535161, 6168237, 6397825, 6168388, 6397894, 5910560, 6413489, 6176685, 6527397, 5910020, 6535171, 5932692, 6538374, 5910557, 5932712, 6527353, 5910014, 5932794, 6176670, 6397897, 6397821, 6527386, 6538364, 6176702, 6397870, 5910556, 6168403, 5933382, 6397815, 6168397, 6535184, 6527406, 6527444, 5910024, 6527370, 6538366, 6527341, 6527411, 5932779, 6527354, 5932631, 5933393, 6170244, 6168413, 6397806, 6351447, 6527428, 5932655, 6527312, 6170224, 5932637, 6397869, 6535157, 6397817, 6535196, 5933399, 6527394, 6176697, 6176694, 6527380, 6527382, 5910016, 6527447, 6538390, 6527358, 6335158, 6535194, 5933404, 5933405, 6170222, 6527437, 6397862, 6351457, 6527435, 6575871, 6622515, 6575911, 6674000, 6575919, 6671486, 6674008, 6674009, 6730388, 6674045, 7023551, 6622540, 6575897, 6673994, 6673996, 7023565, 7023575, 7023531, 6575882, 6575929, 6979013, 6671481, 6674048, 6609127, 6622538, 6622514, 6671490, 6671477, 7023573, 6575928, 6674006, 6671492, 7023569, 7023564, 7023527, 7023529, 6674016, 6575885, 6575896, 6730384, 6575932, 6575881, 6674043, 7023524, 6674015, 6622517, 6674051, 6674031, 7023567, 7023535, 6609114, 6575891, 6730401, 6674010, 6674003, 6609112, 6671482, 7023561, 6575878, 6575933, 6622530, 6674004, 6674044, 6979012, 7023571, 6674021, 7023520, 6730381, 7023549, 6674022, 7023543, 6622532, 6609115, 6609128, 6674034, 6575869, 6671488, 6730376, 6972844, 6674001, 6575913, 7023534, 6674017, 6609124, 6575888, 6673998, 6555225, 6575899, 6674011, 6609110, 6622516, 6730371, 6413487, 5910547, 6535175, 6170207, 6176698, 6168379, 6168387, 5910545, 6527389, 6538380, 6176701, 6176678, 6351456, 6527346, 5932802, 6527326, 6527300, 6538376, 6176703, 6535162, 6168266, 5910542, 6397812, 6527408, 6527436, 6527443, 6168246, 6527372, 6168259, 6168258, 5932799, 6176672, 5932630, 6535190, 6535174, 6168252, 6527344, 6397849, 6397853, 6397895, 5932704, 6168382, 6170231, 6527356, 6176700, 6527338, 6527387, 5933383, 5933396, 6527325, 6168223, 6397872, 6397847, 6168225, 6170215, 6538377, 5933625, 6527365, 5932694, 6535164, 6538359, 6168405, 5932689, 6527448, 5910539, 5910548, 6170249, 5932803, 6527384, 6527306, 5910561, 5933349, 5933359, 6538373, 6527391, 5932628, 5932640, 6527305, 5933373, 6168418, 6168234, 5932635, 6527332, 6527297, 5932786, 6413485, 6168374, 6168414, 6397867, 6168240, 6535195, 6538360, 6535200, 6176675, 6397838, 6168375, 6176687, 5933379, 5932642, 6538388, 6535197, 6168264, 6527433, 6527335, 6168410, 6168217, 6351448, 7023580, 7023539, 6555211, 7023518, 6972809, 6575908, 7023550, 6673992, 6575876, 6609118, 7023574, 6972838, 6671479, 7023576, 6622518, 7023554, 6972834, 6972814, 6972817, 7023523, 6555219, 7023542, 6622524, 6575900, 6555208, 6555207, 6671478, 7023547, 6674042, 7023521, 6555212, 7023560, 7023517, 6671491, 7023558, 6674007, 6674026, 6730373, 6575936, 7023557, 6671480, 6575930, 6575903, 6609117, 6972845, 6979014, 6674033, 6674028, 6575901, 6575914, 6622533, 6972840, 7023546, 7023519, 7023528, 6972843, 6674020, 6555222, 6972835, 6575909, 6674047, 6730368, 7023533, 6575884, 6575907, 7023530, 6555210, 6730403, 7023563, 6671495, 6575910, 6527407, 6413496, 5933400, 5933624, 6168227, 6527452, 5933384, 6170241, 6170250, 6527322, 6535191, 5933358, 6397896, 6527400, 5933370, 6538368, 6170245, 6170226, 6527430, 6397833, 6335159, 6535180, 6527352, 5932795, 6527329, 6397852, 5932690, 6170217, 6527368, 6527405, 6397876, 6527373, 6397823, 6535176, 6527302, 6397841, 5933390, 6527303, 6168236, 6351436, 5910029, 6176699, 5910552, 5932706, 5933623, 6538352, 6538381, 6527307, 6527340, 5932691, 5932711, 6527451, 6527369, 5932629, 6176671, 6397889, 6168235, 6527379, 6397834, 6413498, 6170243, 6168406, 5932806, 6168247, 6535201, 6176683, 6527426, 5933367, 6538358, 5932650, 6170214, 6538378, 6527425, 5932783, 6397854, 6538355, 6527445, 6176668, 6351432, 6335153, 6351442, 6527419, 6527423, 6351449, 6535158, 6674012, 6972846, 6622521, 7023579, 6972812, 6972822, 7023559, 6972813, 6730404, 7023568, 6972832, 6730385, 6575915, 7023556, 6972837, 6979005, 7023562, 6730369, 6730400, 6575905, 6575883, 6609109, 7023541, 6972811, 6979010, 6972821, 6622539, 7023536, 7023532, 6673997, 6671484, 7023555, 6622534, 6609125, 6575935, 6622531, 6972836, 6972825, 6674035, 7023537, 6575874, 6972816, 6555221, 6575912, 6575922, 6972829, 6622525, 6674013, 6671494, 6575931, 6972826, 6972842, 6609121, 6673999, 6397878, 6413490, 6527357, 6351437, 6168369, 6170239, 6979002, 6972818, 6575924

Distribution pattern

Nationwide and Australia, Austria, Belgium, Brazil, Chile, Canada , China, Colombia, France, Germany, Great Britain, Greece, Guatemala, India, Italy, Japan, Korea, Luxembourg, Malaysia, Netherlands, New Zealand, Portugal, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand

device · product 20 of 24

Exactech Equinoxe Constrained Humeral Liner: Item Numbers: a) 320-40-10, b) 320-40-13, Shoulder Arthroplasty

Z-1421-2024
Recall number
Z-1421-2024
Initiated
March 06, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Exactech, Inc.
Quantity
447 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH).

Code information

a) 320-40-10, UDI/DI 10885862535054, Serial Numbers: 5937242, 5910691, 5937233, 5936848, 6062040, 5936849, 6197662, 6197672, 6197682, 6197680, 6197683, 6197674, 6413423, 6062107, 6200990, 6046848, 6197006, 6062047, 5910110, 6413379, 6198008, 6197004, 5936902, 6484655, 5937219, 6197676, 5936834, 6533569, 6197660, 5936882, 6533590, 5910120, 6046849, 6046836, 6062039, 6046843, 6046847, 6413376, 6533602, 6533603, 6533605, 6533593, 6533595, 6533596, 6197026, 6484652, 6484654, 6484665, 6484672, 6198014, 6646211, 5910690, 5936906, 6198016, 6046852, 5937248, 5937208, 6533421, 5936873, 6533292, 6200998, 5936825, 6200968, 6533303, 5910109, 6197681, 5937249, 5937216, 6413403, 6198001, 6197003, 6533302, 6200966, 5937235, 6062099, 6062068, 6197025, 6062095, 6646201, 6673947, 6413375, 6062034, 5937245, 6198002, 6062042, 6413412, 5936866, 6062096, 5910123, 6062051, 6062036, 5936910, 6200985, 5936878, 6200982, 6533422, 6413386, 6197667, 5936869, 6197005, 6200976, 6413408, 6197663, 5937234, 6200973, 6062069, 5937236, 6533279, 5937241, 6533424, 6046833, 6062046, 6197008, 6533579, 6533577, 6046839, 5937240, 5936890, 5937192, 5936831, 6197995, 5910112, 6198009, 6062065, 6533448, 5936846, 5936821, 6413421, 5936850, 6062033, 5910116, 6533429, 6413406, 6533571, 6561069, 6561068, 6673953, 6673959, 6733646, 6673963, 6413380, 6197669, 6413420, 6413405, 6201008, 6197664, 5910108, 6533581, 5937244, 6533270, 5936897, 6062097, 6062037, 5936857, 6413388, 6413385, 6197679, 5910694, 6533280, 6533288, 6046845, 6062100, 6484658, 5936868, 6062070, 6200972, 6198015, 6197996, 6533283, 6197677, 5910127, 5936908, 6484674, 5937238, 6413424, 6200995, 6533295, 6046841, 5936898, 5910124, 6200992, 6046826, 6533442, 6046854, 6533438, 6197666, 6646235, 6646214, 6561058, 6646233, 6750051, 6673951, 6788613, 6733650, 6646202, 6561057, 6750057, 6561063, 6788604, 6750060, 6533567, 6198004, 5937215, 5937230, 6046829, 6533601, 6936457, 6936444, 6733638, 6673957, 6936431; b) 320-40-13, UDI/DI 10885862535061, Serial Numbers: 5958375, 6167598, 5958397, 5958376, 5958019, 6040054, 5869660, 6007206, 5958036, 6007204, 6040038, 6040041, 6252797, 6252808, 6008371, 6053048, 6040057, 6052792, 6007215, 6007265, 6484864, 6259930, 6008365, 6167606, 5958395, 6008354, 5958023, 6053042, 6007213, 5958035, 6259914, 6046949, 6046945, 6170267, 6252800, 6046941, 6259924, 6533939, 6533942, 6484863, 6484867, 6484874, 6484895, 6533945, 6533946, 6575118, 6575140, 6575136, 6575153, 6575167, 6008367, 6252804, 6528111, 6046567, 6528096, 6007243, 5958043, 6007262, 5958377, 6528124, 6008360, 6046948, 6046950, 6484881, 6484904, 5958044, 6046588, 5958037, 6052784, 6170272, 6398022, 6170269, 6046578, 6401912, 6052797, 6170278, 6007259, 6528106, 5958039, 6007210, 6040036, 6052798, 5869659, 5958028, 6008357, 6040056, 6052789, 6575120, 6575105, 6575117, 6730581, 6575113, 6007250, 6008363, 6528085, 6259916, 6007198, 6167591, 6484869, 6528092, 5958384, 6170277, 6052794, 6528078, 6528100, 6053063, 6528094, 6484873, 6007193, 6398012, 6170260, 6007255, 6170271, 6252812, 6398020, 6401906, 6053046, 6046929, 6167587, 6170258, 6053047, 6040037, 6046933, 6397999, 6484896, 6007214, 6046574, 6053049, 6008364, 6528064, 5958022, 6528081, 6046585, 6401905, 6007194, 6252801, 6730584, 6575162, 6575164, 6646308, 6575103, 6730086, 6730056, 6730572, 6575111, 6730063, 6730586, 6575144, 6575130, 6575142, 6730571, 6575148, 6730602, 6575150, 6575165, 6575110, 6575116, 6730084, 6398000, 6053052, 6053055, 6046583, 6401913, 6252794, 6167589, 6484880, 6167596, 5958380, 6484876, 5958367, 6401908, 5958042, 5958393, 6484898, 6040031, 6533940, 6167604, 6052804, 6398001, 6259909, 6401889, 6528120, 6040051, 6040034, 6007209, 6401898, 6046938, 6046940, 6046925, 6167595, 6008366, 6528093, 5869658, 6528099, 5869662, 5958387, 5958391, 6398015, 6007202, 6484893, 6259912, 6046582, 6167593, 6007241, 6046570, 6167603, 6167607, 6484909, 6167609, 6046572, 6259934, 6252802, 6575138, 6646316, 6575151, 6575173, 6575159, 6730579, 6730059, 6575107, 6575169, 6575170, 6730089, 6575109, 6730566, 6646303, 6730567, 6730078, 6397993, 6046936, 6528075, 6040028, 6167600, 6528073, 6401887, 6730599;

Distribution pattern

Nationwide and Australia, Austria, Belgium, Brazil, Chile, Canada , China, Colombia, France, Germany, Great Britain, Greece, Guatemala, India, Italy, Japan, Korea, Luxembourg, Malaysia, Netherlands, New Zealand, Portugal, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand

device · product 21 of 24

Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b) +2.5mm, Item Number 320-42-03; Shoulder Arthroplasty

Z-1422-2024
Recall number
Z-1422-2024
Initiated
March 06, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Exactech, Inc.
Quantity
24303 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH).

Code information

a) Item number 320-42-00, UDI/DI 10885862086693, Serial Numbers: 0982062, 1064609, 1093925, 1000132, 1000124, 1064624, 1000137, 1064629, 1064643, 1064639, 1093902, 1064617, 1093913, 1093909, 1093905, 1000121, 1000115, 1064610, 0982056, 1000123, 0982059, 1000128, 0982053, 0982073, 0982064, 0982066, 0982076, 0982063, 0982071, 0982065, 1064636, 0982074, 1064642, 0982075, 1000136, 1000135, 1000131, 1093931, 1000130, 0982070, 1000117, 1000113, 1064634, 1000129, 1064623, 1093910, 1000116, 0982055, 1064594, 1064600, 1064614, 1064638, 1064641, 1000126, 1000122, 0982058, 1064633, 1093912, 1093939, 1093907, 1093922, 1093923, 1093928, 1093929, 1100342, 1064611, 1093918, 1100320, 1100347, 1100359, 1064602, 1064640, 1064606, 1064631, 1064607, 1064604, 1100357, 1100361, 1100317, 1093924, 1100349, 1100327, 1000114, 1064625, 1100345, 1100353, 1000125, 1064598, 1093908, 1064632, 1064612, 1064595, 1000138, 1093919, 1000119, 1000120, 1064596, 1100331, 1100336, 1064635, 1093935, 1100324, 1064622, 1093901, 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Distribution pattern

Nationwide and Australia, Austria, Belgium, Brazil, Chile, Canada , China, Colombia, France, Germany, Great Britain, Greece, Guatemala, India, Italy, Japan, Korea, Luxembourg, Malaysia, Netherlands, New Zealand, Portugal, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand

device · product 22 of 24

Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty

Z-1423-2024
Recall number
Z-1423-2024
Initiated
March 06, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Exactech, Inc.
Quantity
3648 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH).

Code information

a) Item number 320-42-10, UDI/DI 10885862086716, Serial Numbers: 0982890, 0982906, 0982900, 0982901, 1034066, 1034062, 1034064, 1034082, 1034089, 1034067, 1034068, 1034078, 1034097, 1071503, 1071501, 1034079, 1071494, 0982898, 1034071, 0982896, 1034092, 1071491, 0982914, 1034087, 1071461, 1071505, 1071500, 0982891, 0982894, 1252956, 1252973, 1252999, 1252980, 1252983, 1092837, 1034077, 1034084, 1071486, 1034075, 1071488, 0982915, 1071473, 0982892, 1380140, 1252966, 1395492, 1416391, 1380144, 1457713, 1457706, 1416390, 1463034, 1252962, 1395487, 1071474, 1071506, 1071492, 1071482, 1034072, 1395489, 1457721, 1457718, 1252988, 1252965, 1252972, 1252970, 1463025, 1548052, 1416395, 1531187, 1463038, 1524696, 1524701, 1531185, 1463035, 1395488, 1531190, 1253005, 1548048, 1548054, 1548058, 1253007, 1252991, 1762710, 1762694, 1770118, 1762690, 1916454, 1916461, 1770109, 1829486, 1829488, 1829489, 1770122, 1785631, 1785632, 1785634, 1785635, 1829482, 1882451, 1882453, 1034102, 0982895, 0982889, 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Distribution pattern

Nationwide and Australia, Austria, Belgium, Brazil, Chile, Canada , China, Colombia, France, Germany, Great Britain, Greece, Guatemala, India, Italy, Japan, Korea, Luxembourg, Malaysia, Netherlands, New Zealand, Portugal, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand

device · product 23 of 24

Exactech Equinoxe REVERSE SHOULDER,46mm Humeral Liner, a) +0mm, Item number 320-46-00, b) +2.5mm, Item Number 320-46-03; Shoulder Arthroplasty

Z-1424-2024
Recall number
Z-1424-2024
Initiated
March 06, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Exactech, Inc.
Quantity
1970 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH).

Code information

a) Item number 320-46-00, UDI/DI 10885862086730, Serial Numbers: 0984597, 0984599, 0984577, 0984598, 0984588, 0984582, 0984590, 0984601, 1014640, 0984592, 0984594, 1014637, 1014644, 1135617, 1135600, 1135635, 1135609, 1135637, 1135618, 1135631, 1135624, 1135614, 1135628, 1135616, 1135601, 1135625, 1135602, 1135641, 1135620, 1014641, 1014657, 0984587, 1014654, 1014653, 1014649, 0984596, 1014651, 1135639, 1135642, 1135638, 1135634, 1135610, 1135621, 1135644, 1135605, 1135615, 1135629, 1135627, 1135623, 1014656, 1014655, 0984580, 0984581, 0984595, 1407906, 1407911, 1439261, 1501665, 1407909, 1439257, 1407916, 1516747, 1407902, 1501663, 1501662, 1516748, 1501666, 1516751, 1407899, 1439267, 1501659, 1516745, 1135611, 1135636, 1135630, 1014646, 1014643, 1439263, 1407914, 1545607, 1407908, 1501658, 1516744, 1407905, 1545609, 1439265, 1407904, 1407910, 1516750, 1545610, 1501664, 1516746, 1653764, 1831448, 1653753, 1653763, 1831457, 1653784, 1831438, 1653758, 1831437, 1831446, 1653756, 1653794, 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6591879, 6561026, 6591870, 6591900, 6591901, 6901419, 6901414, 6709361, 6591850, 6907083, 6907082, 6901424, 6561020, 6907084, 7056699, 6591903, 6901418, 6591877, 6907080, 7017205, 6591897, 6901415, 7017196, 6591907, 6591855, 6591869, 6591863, 6591853, 6591858, 6591896, 6591902, 6907095, 6561029, 6591873, 6907092, 7017210, 7056712, 6591878, 4949637, 5152102, 5027726, 5056440, 5152116, 6164331, 6349199, 5967662, 6349192, 6164300, 6164342, 6164297, 6164316, 7056710, 6561042, 6591881, 7056711, 6561027, 6901426, 6591876, 6901413, 7017212, 6591885, 7056698, 7056707, 7017209, 6907086, 6709362, 7017213, 6591874, 6907087, 7056715, 6901420, 6907089, 6907085, 6561034, 6349186, 5967657, 5967655, 6164306, 5866606, 5866601, 6907078, 7017198, 6591887, 6591882, 7056705, 6591856, 7056709, 7017201, 7017199, 6561018, 7017211, 6901431, 6591890, 6591861, 7056696, 6164320, 7017203

Distribution pattern

Nationwide and Australia, Austria, Belgium, Brazil, Chile, Canada , China, Colombia, France, Germany, Great Britain, Greece, Guatemala, India, Italy, Japan, Korea, Luxembourg, Malaysia, Netherlands, New Zealand, Portugal, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand

device · product 24 of 24

Exactech Equinoxe REVERSE SHOULDER,46mmConstrained Humeral Liner, a) +0mm, Item number 320-46-10, b) +2.5mm, Item Number 320-46-13; Shoulder Arthroplasty

Z-1425-2024
Recall number
Z-1425-2024
Initiated
March 06, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Exactech, Inc.
Quantity
591 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH).

Code information

a) Item number 320-46-10, UDI/DI 10885862086754, Serial Numbers: 0984536, 0984533, 0984546, 1018089, 1018095, 1018091, 1018097, 1018084, 0984530, 0984547, 0984529, 0984532, 1332742, 1361390, 1545622, 1545624, 1361388, 1466508, 1466510, 1466513, 1466514, 1469127, 1466511, 1469130, 1683551, 1683520, 1683540, 1683541, 1683545, 1683548, 1683552, 1683554, 1683557, 1683515, 1332737, 1469126, 2010727, 1683514, 1683532, 1683529, 1683536, 2118729, 2118731, 2104263, 2118733, 2118732, 0984535, 1332736, 1361392, 1683527, 2010723, 1683558, 2010721, 1683523, 1683528, 2194597, 2265086, 2296247, 2296249, 2104265, 2265088, 2394874, 2394872, 2104261, 2151089, 2427260, 2427269, 2296245, 2532045, 2394871, 2296262, 2532055, 2151096, 2265081, 2532038, 2532065, 2532066, 2532061, 1466512, 1683556, 1683531, 2194603, 2427272, 2151091, 2532054, 2532053, 2532037, 2532044, 3533621, 2847727, 2847735, 1683544, 1683524, 2118730, 2104264, 2532058, 2194598, 2265090, 2532059, 2532052, 2532048, 2532035, 2532057, 2532060, 2532050, 2394868, 2847740, 2847747, 2847731, 3645487, 3905359, 3905367, 2427262, 2427264, 2532063, 2847737, 3533628, 4341764, 4341770, 3905370, 3905361, 4341771, 4426302, 4426303, 4426306, 4426308, 4426301, 3905383, 3645478, 2847744, 2847725, 3645475, 3645479, 3825547, 3825543, 4426305, 4426318, 4426313, 4341756, 4341762, 4769063, 4857596, 4719181, 4805400, 5076014, 5013622, 5013621, 4805392, 4719182, 4857595, 4944150, 4944152, 4857603, 4805402, 5076021, 5013616, 5013637, 4944148, 3533623, 2847746, 4341760, 3825534, 3905360, 4341758, 3905374, 3905373, 4769064, 4944159, 4803379, 4805406, 5013632, 5044684, 5013615, 5013635, 4944154, 4805401, 4857600, 4769070, 5165732, 5165740, 5165745, 5044679, 3825535, 3905377, 3825538, 3825551, 4805382, 5044682, 5013626, 5165747, 5076023, 4944168, 4805379, 4805381, 4805384, 5165757, 5867596, 6271755, 6271759, 5867598, 5867608, 4426309, 4805385, 4944149, 5165756, 5013628, 5165752, 4944161, 5013617, 6347991, 5867602, 6271743, 6271750, 6271742, 6347969, 6594357, 4944163, 5013620, 4857593, 4769073, 5076013, 4857604, 4857606, 4756178, 4719185, 6271751, 6271744, 6271762, 6271746, 6594355, 5013633, 5044690, 6347990, 5867583, 5867590, 6347997, 5867593, 6347968, 6271763, 6594360, 6347988, 5867601, 5867594, 6347970, 6594353, 6594359, 6594345, 6271760, 6594343; b) Item Number 320-46-13, UDI/DI 10885862086761, Serial Numbers: 0983443, 0983412, 0983426, 0983423, 0983430, 1069733, 1069752, 1069781, 1069734, 0983434, 0983417, 1069736, 1069735, 0983425, 0983442, 0983427, 1069757, 0983414, 0983419, 0983435, 1069761, 1069773, 1069738, 1069740, 1069747, 1490759, 1490757, 1490762, 1490753, 1546325, 1069770, 1069767, 1490755, 1546322, 1546323, 1546326, 1802197, 1686810, 1802204, 1802901, 1686806, 1686816, 1686821, 1802200, 1802902, 1802904, 1802198, 1686811, 1802196, 1069776, 1069765, 0983436, 1069777, 1490758, 1990103, 1917844, 2027971, 1939803, 1802201, 2027968, 2027972, 2108016, 2108017, 2108013, 1990105, 1686805, 1939802, 2229147, 2132339, 2296907, 2296898, 2296901, 2296911, 2131629, 2229137, 2296897, 2392588, 2392596, 2392600, 2418293, 1546324, 2296905, 2229143, 2131627, 2513181, 2392587, 2418290, 2513173, 2296904, 2296899, 2296888, 2392593, 2392605, 2505459, 2392594, 1802205, 1686812, 1686824, 2505455, 2296908, 2296915, 2296891, 2173989, 2513193, 2418281, 2513179, 2392598, 2513188, 2513183, 2252628, 2513195, 2229150, 2513176, 2834933, 2834945, 2834957, 2834946, 2834947, 1990104, 1939806, 1990101, 2229141, 2513175, 2296889, 2132336, 2513185, 2513186, 2505457, 2296919, 2418278, 2173987, 2418292, 2296900, 2513184, 2131626, 2513190, 2988513, 2988494, 2988514, 2988509, 2795053, 2795052, 2795051, 2795054, 2988503, 2988518, 3901534, 3901529, 3901531, 4115341, 3901523, 2418286, 2392599, 2296892, 2418285, 2513177, 2513172, 2513191, 2132334, 2834934, 2988507, 2834953, 2834939, 2795050, 3901513, 3901528, 3886029, 4115340, 4309970, 4387134, 4127396, 4127400, 4309979, 3901521, 2988521, 2988510, 3901512, 4387118, 4309977, 4127406, 4387116, 4127402, 3901519, 4309976, 4703255, 4963999, 4827125, 4788000, 4827130, 4827145, 4977223, 5027773, 4902312, 5074892, 4902309, 4703261, 4703258, 4703253, 5017482, 4902313, 4827135, 4902311, 4827131, 4827142, 2988497, 2988515, 4309969, 4387131, 4127404, 4309981, 3901530, 4387122, 4127398, 4827120, 4846562, 5017483, 4801490, 4703262, 4827144, 4788001, 5049876, 4977228, 5150219, 4975984, 5027775, 5062075, 4788003, 5207482, 4769028, 4780644, 4691479, 4703266, 5150207, 5150210, 5207471, 4703248, 2988519, 3901520, 3901525, 4115338, 3886033, 4387113, 4387114, 3886028, 4309974, 3901526, 4780641, 5150211, 5017481, 4801495, 4703264, 5074890, 5207476, 5207478, 5207472, 5207480, 4827132, 4691475, 6164395, 5874286, 5874267, 5874265, 6164414, 5874264, 4309968, 4127417, 4127403, 5017485, 5150201, 5062077, 5062083, 4964000, 5027774, 4975985, 4827133, 5874273, 5874260, 6164394, 5874280, 5874281, 5874287, 6164421, 5874270, 5874283, 5874262, 6709483, 4387130, 4309966, 5049878, 5150217, 4827146, 4902315, 4703269, 4703260, 5074891, 5150209, 4780643, 6164401, 5874284, 5874277, 6164405, 6356447, 6164409, 6709485, 6593476, 6593475, 6709475, 6593467, 6709500, 5150220, 5074889, 4975981, 4977225, 6164397, 6356450, 6164399, 6593480, 6593491, 6593486, 6593459, 6709465, 6709481, 6593471, 6709472, 6709484, 6356435, 6164422, 5874274, 6164410, 6356437, 6356434, 6164408, 6593478, 6709493, 6593474, 6593485, 6593473, 6709489, 6593457, 6709468, 6709491, 6164412

Distribution pattern

Nationwide and Australia, Austria, Belgium, Brazil, Chile, Canada , China, Colombia, France, Germany, Great Britain, Greece, Guatemala, India, Italy, Japan, Korea, Luxembourg, Malaysia, Netherlands, New Zealand, Portugal, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand